Clinical Trials
Oncology
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
Apr 2013The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.
Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
Apr 2013Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study. Group 1: Hemi-ablation of the prostate at the side of the positive biopsies (hemi-ablation) Group 2: Total ablation of the prostate (total ablation) Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.
A Multicenter Phase II Pilot Open Label (BKM120)
Apr 2013Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas
A Multicenter Phase II Pilot Open Label (BKM120)
Apr 2013Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas
Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)
Apr 2013This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated four weeks after end of treatment. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Apr 2013The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Apr 2013The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma
Mar 2013Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.
Vincristine or cis-platin, both in combination with gemcitabine or pemetrexed for the treatment of advanced non-small cell lung cancer – VIP trial
Mar 2013Primary objectives of the trial: quality of life; treatment side effects
Sutent Rechallenge In mRCC Patients (RESUME)
Mar 2013Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Sutent Rechallenge In mRCC Patients (RESUME)
Mar 2013Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer (BASALT-2)
Mar 2013The Phase Ib part of the study aims to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study is to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC.
Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)
Mar 2013To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.
Atorvastatin and Prostate Cancer (ESTO1)
Mar 2013This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.
Botulinum Toxin for Stomach Cancer Treatment
Mar 2013Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.
NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years
Mar 2013The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
Phase I Trial: T4 Immunotherapy of Head and Neck Cancer
Mar 2013The overall goal of this study is to investigate the safety of T4 immunotherapy when administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck (SCCHN) that is not suitable for conventional active therapy. The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z. Engineered T-cells will be injected directly into the tumour site. Patients will not be lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7 through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated that up to 30 patients will be enrolled over the course of the study.
TMMR Register Study (TMMR-RS)
Mar 2013TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in high risk situations. More and more this therapeutic strategy is implemented in clinical routine in specialized cancer centres, thus, treatment of cervical cancer could be performed for these stages in a systematically defined and reproducible radicality; adjuvant radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource assignment in primary treatment dramatically. Due to the nerve-sparing character of the procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit the patient. This study is designed to follow up the results of this therapeutic concept adapted to clinical routine in a multiinstitutional register study accompanied by detailed assessment of pathological work-up, quality of life and bladder and sexual function following surgery.
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia (LAMVIRE)
Mar 2013Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer (ADAPT)
Mar 2013The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.
Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer
Mar 2013Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.
A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer
Mar 2013The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).
NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer
Mar 2013This randomized, parallel cohort, two stage, double-blind, placebo-controlled study will evaluate the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive primary breast cancer prior to definitive surgery (neo-adjuvant setting).
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Mar 2013The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.
A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole
Mar 2013To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole
Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma
Mar 2013The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer
Mar 2013This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions (TPVB)
Mar 2013Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)
Mar 2013This study will treat patients with advanced NSCLC with a combination of standard first line platinum-containing doublet chemotherapy and selumetinib. It will help to understand what is the best tolerated combination of doses of the three agents, and what type of side effects may occur when the three agents are given in combination. In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.
Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)
Mar 2013In patients with muscle invasive bladder cancer not suitable for cystectomy or daily radiotherapy we aim to assess: - whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity - the local tumour control rate achieved by hypofractionated weekly radiotherapy - the requirement to treat with adaptive planning.
Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Mar 2013The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.
Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma (SERIO)
Mar 2013This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.
Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer
Mar 2013To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T <5 cm). To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN. To statistically assess SLN positivity and its location within the sbregion. To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
Feb 2013To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients ≥ 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).
Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer (MITO16MANGO2b)
Feb 2013Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.
Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)
Feb 2013Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
A prospective, open, randomized, academic phase II, two-arm trial evaluating the effect of fibrin-coated collagen (TachoSil®) on postoperative pancreatic leakage and fistula formation from the pancreato-enteric anastomosis in patients undergoing partial pancreaticoduodenectomy
Feb 2013To demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis
Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT
Feb 2013The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy (NEURISK)
Feb 2013The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)
Feb 2013The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Feb 2013A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 30 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) (NMIBC TURBT HG)
Feb 2013In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode
Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer
Feb 2013Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cacner with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cacner.
A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Feb 2013The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.
A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
Feb 2013This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Feb 2013The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC
Feb 2013The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment. Secondary objectives of the study are - to assess safety of the treatment modality by collecting data about acute and late toxicity - patterns of local and distant recurrence and relation between the site of local recurrence and the clinical (CTV) and planning target volume (PTV) - survival and cause of death
Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
Feb 2013The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.
A randomized, multicenter, open label phase III study to evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy.
Feb 2013To compare the length of time it takes for the primary breast cancer to recur after treatment with preoperative chemotherapy followed by surgery between the 2 treatment arms.
Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (TOMMY)
Feb 2013In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.
Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
Feb 2013Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward). Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.
Randomised, open-label phase II study to compare the safety and efficacy of lapatinib plus trastuzumab or lapatinib plus capecitabine in trastuzumab-resistant HER2-overexpressing metastatic breast cancer
Feb 2013Estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival (PFS)
A Study Comparing AZD2014 vs Everolimus in Patients With Metastatic Renal Cancer (ZEBRA)
Feb 2013When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 2 years of the dignosis. Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF which is important in treating kidney cancer. Although the results with this drug are impressive, patients develop resistance to the drug and stop therapy. It is currently standard practice is to give everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the average time to cancer regrowth with everolimus is only 5 months. It is thought this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2). Therefore further improvement in treating patients is required. AZD2014 is a promising new drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in renal cancer as it theoretically could may have advantages over everolimus. Therefore study compares AZD2014 to everolimus in the setting where everolimus is used as standard of care. (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus.
Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques (MALTA)
Feb 2013One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.
Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)
Feb 2013This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)
Feb 2013Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)
A Trial of AZD4547 for Breast Cancer That is Oestrogen Receptor Positive and Has Got Worse Despite Having Anastrozole or Letrozole (RADICAL)
Feb 2013This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Feb 2013The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.
A phase II, randomized study of paclitaxel with gdc-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer
Feb 2013To evaluate the efficacy (as measured by progression-free survival [PFS]) of paclitaxel + GDC-0941 versus paclitaxel + placebo in patients with and without PIK3CA mutations and in all treated patients
Predicting Outcome in Cervix Carcinoma: a Prospective Study (POCER)
Feb 2013The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.
A Phase I Trial of AZD3965 in Patients With Advanced Cancer
Feb 2013The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed and what happens to AZD3965 inside the body.
The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma
Feb 2013To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or after prior first-line immunotherapy for metastatic disease.
An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)
Feb 2013This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.
Nintedanib(BIBF1120) in Thyroid Cancer
Feb 2013Angiogenesis pathway represents a set of potential targets for targeted therapies in thyroid cancer. VEGF receptors (VEGFR) and especially VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. Vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFR-1, VEGFR-2) as well as receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed in thyroid cancer. These receptors are also expressed on perivascular cells, such as pericytes and smooth muscle cells, that are also involved in tumor angiogenesis. Tyrosine kinase inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. Vandetanib is approved for MTC and it is expected soon that sorafenib will be approved for differentiated thyroid cancer. The treatment options for patients with DTC and MTC who have progressed on one line of therapy are limited and there is no treatment that is generally considered as standard of care. No clinically meaningful benefit has yet been demonstrated with cytotoxic chemotherapy. On the other hand patients are still in good general condition and may still benefit from treatment and experience survival prolongation. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF therefore acting potentially not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of its multi-kinase activity rationale exists to develop it in both MTC and DTC. By targeting these three major angiogenesis signaling pathways it is believed that nintedanib can prevent further tumor growth and related tumor escape mechanisms. This also means that nintedanib may be active in patients who have progressed on agents that target only one pathway.
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
Feb 2013To assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed or refractory NHL who have received at least one prior therapy containing rituximab as one of the treatments.
A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (UV1-hTERT2012L)
Feb 2013In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Feasibility Study Of Identification Of Sentinel Node(s) In Breast Cancer (SENTIMAG)
Feb 2013The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer
Feb 2013This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.
Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans
Feb 2013Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation. The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.
Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
Feb 2013The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.
A phase IV, postmarketing, open-label, extension (rollover) study of vemurafenib in patients with BRAFV600 mutation−positive malignancies previously enrolled in an antecedent vemurafenib protocol
Feb 2013To provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated for an antecedent vemurafenib protocol without meetings its definite criteria for disease progression there and may potentially benefit from continued treatment with vemurafenib
Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay
Feb 2013The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Feb 2013To determine if the treatment of rilotumumab in combination with ECX significantly improves overall survival (OS) as compared with rilotumumab-placebo in combination with ECX in subjects with unresectable locally advanced or metastatic MET-positive gastric or GEJ adenocarcinoma.
Identification, Molecular Epidemiology Angiosarcoma of the Liver France (ANGIHE)
Feb 2013The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc
The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer (STOPEROPCHEM)
Feb 2013Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy (NoHarm)
Feb 2013The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer
Feb 2013Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall survival rates for this disease remain poor. During the last years the combination of cetuximab with standard chemotherapy or radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or head and neck cancer. The results obtained from theses studies were very encouraging and led to the initiation of active clinical research in esophageal cancer patients with antibody inhibition of the EGFR. The first data in this indication are encouraging showing that cetuximab can safely be added to chemoradiation for esophageal cancer patients with first hints of efficacy. Based on the experiences with cetuximab in colorectal cancer and in combination with radiotherapy in head and neck cancer, the aim of the present study is to evaluate the feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin and radiotherapy in patients with esophageal cancer and to assess if the overall survival rates can be increased by addition of an EGFR-targeted therapy.
Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer (BRASTEGAC)
Feb 2013The objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Feb 2013Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.
Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital. (ALL)
Feb 2013This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia (AML)
Feb 2013The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.
Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas (LeMLAR)
Feb 2013Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab (IIPOP)
Feb 2013Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)
Feb 2013The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy, costs and safety.
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)
Feb 2013The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
Parp Inhibitor in Advanced Non-Small Cell Lung Cancer (PIN)
Feb 2013The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death.
A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer. (IRIS)
Feb 201370% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow and are likely to respond to hormone treatment. This type of treatment reduces the amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not being controlled by one class of AI are switched to the other class of AI. The reason for this is that some cancer cells can become resistant to one class but are still sensitive to the other class. However, oestrogen can be made in the body by two pathways and AIs block only one of these pathways. A new drug called Irosustat can reduce the production of oestrogen in the body by blocking the second pathway. This study is investigating whether adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further reduce the amount of oestrogen in the body and therefore control the breast cancer better. 27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer that is not being controlled by their current AI treatment will be recruited in this study from 9 United Kindgom (UK) hospitals. Eligible patients will receive 40mg of Irosustat once daily in addition to the AI on which they progressed. Patients will receive Irosustat for as long as it controls their cancer or until they have side effects that stop them from taking treatment. Patients will be seen monthly for the first 6 months and every 3 months thereafter. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue and blood samples.
NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer
Feb 2013To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression- free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)
Feb 2013A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
The Swedish Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)
Feb 2013A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with isolated liver metastases from uveal melanoma.
Feasibility of Microdialysis (MTM COLON I)
Feb 2013The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
An Observational Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Jan 2013This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTFreedom)
Jan 2013The main purpose of the study is to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery (CARLHA)
Jan 2013As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.
A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer
Jan 2013The main objectives of this study are: - to compare the overall survival of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - to compare overall response rate as determined by immunerelated response criteria of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - Evaluate safety and tolerability profile of MK3475 in previously treated subjects with squamous non-small cell lung cancer
Physiological Effects of Altering Cancer-related Inflammation
Jan 2013This prospective pilot study will examine whether the previously reported effects of NSAIDs on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.
Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group.
Jan 2013The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification in case of a positive FDG-PET/CT after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen.
Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)
Jan 2013The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.
Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")
Jan 2013Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis. In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
Jan 2013Whole body MRI with diffusion weighted imaging is a useful imaging tool - staging and diagnosis - therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).
Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")
Jan 2013Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis. In this prospective translational study, a preclinical and a clinical phase are designed. As a first step, the main goal is to define the characteristic molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes plasma levels and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
Jan 2013The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)
Jan 2013Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.
Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)
Jan 2013Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better antiproliferative activity on resistant cell lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to registration of the compound. It showed a favorable toxicity profile with an interestingly low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of this taxoid in breast cancer is reasonable.
A phase Ib/II open-label, multi-center study of the combination of BYL719 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors
Jan 2013Phase IB To estimate the maximum tolerated dose MTD(s) and/or identify the recommended phase II dose(s) of BYL719 in combination with AMG 479 (ganitumab) in selected patients with solid tumors Phase II To estimate the antitumor activity of BYL719 in combination with AMG 479 (ganitumab) in the following Phase II populations: Arm 1: Patients with PIK3CA mutated or amplified hormone receptor positive breast cancer Arm 2: Patients with PIK3CA mutated or amplified ovarian cancer
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (Koralle)
Jan 2013This observastonal multicenter study will evaluate the differences of progression-free survival in defined subgroups of patients with metastatic colorectal cancer receiving Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data will be collected for up to 5 years.
Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults (FUBEO)
Jan 2013The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery. Second purpose : to define apparent diffusion coefficient value of the bone sarcoma. Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.
A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)
Jan 2013In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (Koralle)
Jan 2013This observastonal multicenter study will evaluate the differences of progression-free survival in defined subgroups of patients with metastatic colorectal cancer receiving Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data will be collected for up to 5 years.
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
Jan 2013To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neck
Jan 2013Response Rate (CR, PR) 3 months after end of therapy (RECIST)
ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)
Jan 2013This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.
Response of Hepatic Tumors to Radioembolization (RESRAD)
Jan 2013The study enrolls patients with non-resectable or borderline resectable hepatocellular carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis. Patients are not a candidates for liver transplantation and have only limited extrahepatic disease. All patients are treated with radioembolization. Primary endpoint is the percentage of patients that can be downstaged to resectability. Secondary endpoints are radiologic response to radioembolization,tissue response to radiomembolization and systemic immune response and intra-tumoral T-cell response to radioembolization.
Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer (VESPER)
Jan 2013Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.
Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2) (Nilo Post-STIM)
Jan 2013The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.
Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)
Jan 2013This clinical study evaluates the efficacy and safety of regorafenib in patients with advanced liver cancer who have progressed on sorafenib treatment.
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Jan 2013The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
Jan 2013This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs.
National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT)
Jan 2013The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities.
A Multi-Center, Randomized, Controlled, Two-Arm, Pivotal Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma
Jan 2013To evaluate the overall survival (OS) in patients with advanced MEL receiving either MK-3475 or IPI.
NSCLC Burden of Illness Study (LuCaBIS)
Jan 2013The aim of this observational study is to identify and quantify the humanistic and economic burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data collection will be conducted through patient medical record abstraction and patient survey.
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
Jan 2013This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)
Jan 2013The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers
The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer
Jan 2013To study the concordance of sentinel node (SN) localization between preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the intra-operative SN procedure for low stage cervical cancer.
Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial
Jan 2013To assess the median survival
Oxford Ovarian Cancer Predict Chemotherapy Response 01 (OXO-PCR-01)
Jan 2013The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.
Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane (Evelyn)
Jan 2013Everolimus will be given to patients with metastatic breast cancer who already has a progress taking Everolimus but with a change in the endocrine treatment.
iMRI-guided Brain Biopsies
Jan 2013The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial.
A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer (PACER)
Jan 2013The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.
A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse
Jan 2013The objective of this study is to explore the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on PFS
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
Jan 2013The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
Jan 2013This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
NY-ESO-1 T Cells in OG Cancer (NY-ESO-1 OG)
Jan 2013This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4. The primary objective of response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter.
Study Comparing AEZS-108 to Doxorubicin as a Second Line Therapy of Endometrial Cancer
Jan 2013Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)
Jan 2013The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer (Meta-Four)
Jan 2013HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.
A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID.
Jan 2013To assess the optimal duration of consolidation treatment with nilotinib 300 mg BID in order that patients remain in treatment free remission (≥MR4.0) without molecular relapse 12 months after cessation of nilotinib.
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Jan 2013This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma (AIMM)
Jan 2013The objective of the present trial is: - to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. - to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP - to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP
Effect of chemotherapy on endothelial function in patients with testicular cancer
Jan 2013The aim is to study possible adverse effects of chemotherapy on endothelial function1
SST0001 in Advanced Multiple Myeloma
Jan 2013Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated with cancer metastasis, angiogenesis, and inflammation. The heparanase enzyme is a promising target for development of new anticancer drugs. HS and the structurally related heparin are present in most animal species. As an analogue of the natural substrate of heparanase HS, heparin is considered to be a potent inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity and are strictly related to the anti-heparanase activity. In preclinical murine models SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models, with a significant reduction of subcutaneous growth of different multiple myeloma cell lines, when SST0001 was administered either alone or in combination with dexamethasone. The purpose of this study is to determine the safety and tolerability of escalating doses of SST0001 in the treatment of advanced refractory multiple myeloma.
A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients
Jan 2013To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Jan 2013Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and prior first-line therapy (Ipilimumab-immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival
Tumor Bank for Blood Samples
Jan 2013Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.
Effect of Macrodex versus lactated Ringer on coagulation in major surgery. A randomised clincal trial.
Jan 2013The objective is to assess the coagulation competence of the fluids
Endocuff Adenoma Detection Rate Pilot Study
Jan 2013Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer (plan selection)
Jan 2013This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)
Jan 2013The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.
Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer (ACROBATICC)
Jan 2013A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon Prospective collection of patient reported outcome measures (PROMs)
A phase I/II study of first line Ganetespib with pemetrexed/cisplatin, in patients with malignant pleural mesothelioma
Dec 2012The principal research question for the phase I study is to find the maximum tolerated dose of Ganetespib, and use this information with the number of chemotherapy cycles administered to determine the most appropriate dose of Ganetespib for the phase II trial. For the phase II study, the principle research question is to determine whether adding Ganetespib to pemetrexed and cisplatin using the dose from the Phase I part of the study, versus pemetrexed and cisplatin chemotherapy improves progression free survival (first disease progression or death of any cause).
A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission
Dec 2012The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age >= 55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy
A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
Dec 2012To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D) of BEZ235 when administered twice daily (BID) as a single agent in patients with relapsed or refractory acute leukemia To determine the dose-limiting toxicity (DLT)
Spectroscopy From Duodenum
Dec 2012Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
Efficacy Study of Sunitinib and Everolimus (Rotational Versus Sequential Arm) in Patients With Metastatic Clear Cell Renal Cancer (SUNRISES)
Dec 2012The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Dec 2012To determine whether abiraterone acetate in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
Study of ACE-536 for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Dec 2012The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with low or intermediate-1 risk MDS.
Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (MAESTRO)
Dec 2012This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.
A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment versus Chemotherapy for Subjects with Advanced Melanoma who Progressed after Initially Achieving Disease Control with Ipilimumab Therapy Protocol Amendment 01- Pharmacogenetics Blood Sample Amendment, site specific (version 1.0, dated 27-Aug-2012)
Dec 2012The purpose of the study is to compare the 18-month overall survival rate in subjects with advanced melanoma receiving ipilimumab monotherapy (3 mg/kg) as retreatment versus chemotherapy of investigator’s choice in subjects who are randomized at the time of ipilimumab retreatment eligibility. This comparison will be done after the last randomized subject had the chance to be followed for 18 months.
A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
Dec 2012To assess the tumor response rate (defined according to the IMWG uniform response criteria)
A Phase II Trial of combination treatment with Vorinostat, Bortezomib and Dexamethasone in participants with Relapsed Multiple Myeloma
Dec 2012To assess the overall response rate (partial response or better) of patients with relapsed multiple myeloma, after combination treatment with vorinostat, bortezomib and dexamethasone.
A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib
Dec 2012The purpose of this study is to determine the rate of successful treatment-free remission (TFR) within the first 12 months following cessation of treatment in patients who achieved and maintained a molecular response (MR) 4.5 on nilotinib after a switch from imatinib. TFR phase is often referred to as discontinuation phase in other studies.
Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.
Dec 2012To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor
Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer. (Oeso-Chemo)
Dec 2012Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.
Adoptive T cell therapy plus vaccination in metastatic melanoma patients
Nov 2012The primary objective of this study is to demonstrate safety of ACT plus low does IFN-alpha followed by vaccination with autologous tumor cells.
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects with Previously Untreated Unresectable or Metastatic Melanoma Pharmacogenetics Blood Sample Amendment 01- dated 20-sep-12, version 1.0
Nov 2012The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma
EURAD-MR Classification : European Multicenter Study
Nov 2012An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility. This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.
Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.
Nov 2012The main objective of the trial is to prospectively assess the efficacy, toxicity, quality of life with PEG IFN alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0. The primary objective is to determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves relapse-free survival (PFS) as compared to observation.
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Nov 2012Modified progression free survival (mPFS) per independent review facility (IRF)
COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection.
Nov 2012To evaluate the efficacy of dabrafenib and trametinib combination therapy compared to two placebos with respect to relapse-free survival (RFS) in patients with completely resected, histologically confirmed, BRAF V600E/K high-risk, stage III cutaneous melanoma
A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium
Nov 2012To compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Barrett's Intervention for Dysplasia by Endoscopy (BRIDE)
Nov 2012This feasibility study is a vital step towards two trials: (a) a trial to compare the two non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will help us find out whether it will be possible to enroll and retain enough patients by using several centres, and to identify/resolve any other potential barriers to recruitment and retention, including exploring viewpoints of patients and surgeons.
A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib
Nov 2012The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib
Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer (MITO15)
Nov 2012This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer patients with BRCA mutation and BRCAness phenotype. The purpose of this study is to determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.
A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients
Nov 2012The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.
Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
Nov 2012This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the first platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)
Nov 2012Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.
Activity and Safety Study ok BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL)
Nov 2012The aim of this study is to determine the activity , to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under patin and cetuximab-based chemotherapy.
ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)
Nov 2012The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
Randomised phase II study evaluating, as first-line chemotherapy, weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.
Nov 2012To evaluate, as a first-line chemotherapy, the disease control rate (DCR) of weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.
Multicenter, open-label, non-randomized Phase II trial of dasatinib in patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) who meet criteria for late suboptimal response after prior imatinib treatment.
Nov 2012To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
An open label, randomized (2:1) Phase 2b study of Dasatinib vs. Imatinib in patients with Chronic Phase Chronic Myeloid Leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg Imatinib
Nov 2012To compare the rate of major molecular response (MMR) at 12 months after Day 1initiation of first line treatment with imatinib, in patients randomized at month 3 to treatment with dasatinib 100mg QD or imatinib at any dose, after less than optimal response to 1st line imatinib
Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours
Nov 2012High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.
LYmphadenectomy After NeoAdjuvant Chemotherapy (LYANA)
Nov 2012The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy. Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma (PACT-19)
Nov 2012The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic cancer.
Randomized phase II trial with irinotecan as monotherapy compared to irinotecan and bevacizumab (BevIri) for patietns with platinum resistant non-resectable esophagus-, cardia or gastric cancer
Nov 2012To evaluate the efficacy of bevacizumab and irinotecan in combination compared to irinotecan alone in patients with esophagus, cardia or gastric cancer.
Sentinel Node in Ovarian Cancer (SONAR)
Oct 2012As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph node or sentinel node. If the sentinel node does not contain cancer, there is a high likelihood that the cancer has not spread to other lymph nodes. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node technique has been proven to be effective in different cancers such as breast cancer and malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar cancer. Currently sentinel node studies are done for cervix and uterine cancer. The present study determines whether or not a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.
A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancer
Oct 2012To demonstrate the antitumor activity of LDK378, as measured by overall response rate (ORR) to LDK378 by investigator assessment
Variations in plasma concentration in patients with non-small cell lung cancer on fixed-dose erlotinib
Oct 2012The hypothesis of the project is that erlotinib given as at a fixed dose of 150mg to all patients’ results in a variable plasma concentration of the drug. This would in turn lead to a variation in anticancer effect and toxicity. The project will determine the size of this person-person variability. Should a sizeable difference be found, it would indicate the need for further studies of potential differences in anticancer activity and toxicity and a re-assessment of drug dosage.Erlotinib hydrochloride is the active substance of Tarceva, which is used to treat advanced stage non small cell lung cancer and pancreatic cancer. This project deals with non small cell lung cancer (NSCLC) patients only. Erlotinib is a reversible tyrosine kinase inhibitor (TKI), that specifically targets the epidermal growth factor receptor (EGFR), which is sometimes highly expressed and occasionally mutated in various forms of cancer.
A Phase II/III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer
Oct 2012The primary objective of the study is to compare overall survival in chemotherapy-naive patients with metastatic pancreatic cancer receiving gemcitabine 1000 mg/m2 weekly combined with ON 01910.Na at 1800 mg/m2 via 2-hour continuous intravenous infusions administered twice weekly for 3 weeks of a 4-week cycle vs. gemcitabine alone at 1000 mg/m2 weekly for 3 weeks of a 4-week cycle.
Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)
Oct 2012The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)
Oct 2012The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. (1716-12)
Oct 2012This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
A phase III, double-blind, placebo-controlled study of vemurafenib versus vemurafenib plus GDC-0973 in previously untreated BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanoma
Oct 2012To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by prolongation of progression-free survival (PFS), as assessed by the study site investigator.
Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy
Oct 2012This is a randomized Phase III clinical trial in the setting of localized high-risk soft tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy tailored to the specific histology within the family of adult STS. Chemotherapy will be administered for 3 cycles. There will be five histological groups (representing 80% of STS), as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS), synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be, respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included and registered, but treated only by standard chemotherapy. Patients who have already undergone definitive surgery will receive treatment post-operatively and patients needing a re-excision after inadequate surgery will be treated as patients in the two groups, but of course will not be evaluable for response. A centralized pathological review will be performed. Radiological response will be evaluated according to RECIST and to Choi criteria. Pathological response will also be recorded.
A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant
Oct 2012To evaluate the efficacy (as measured by overall survival) of pixantrone plus rituximab compared to gemcitabine plus rituximab in patients with a diagnosis of de novo DLBCL, DLBCL transformed from indolent lymphoma, or follicular grade 3 lymphoma who have relapsed after at least 1 prior chemotherapy regimen and who are not currently eligible for high-dose (myeloablative) chemotherapy and stem cell transplant.
Re-irradiation of High Grade Gliomas: a Quality of Life Study
Oct 2012Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.
Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab (MITO16/MANGO-2)
Oct 2012The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.
A multicenter, single-arm, open-label study with pomalidomide in combination with low dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma
Oct 2012Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone(LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.
A phase III single arm study to evaluate the efficacy, safety and local tolerability of a subcutaneous 3‑month formulation of triptorelin pamoate (11.25 mg) in patients with locally advanced or metastatic prostate cancer.
Oct 2012To confirm the efficacy of triptorelin pamoate (11.25 mg)prolonged release (PR) formulation by inducing castration (defined as serum testosterone level of <50 ng/dL or <1.735 nmol/L) at Day 29 and maintaining castration at Day 183 (after receiving two subcutaneous (s.c.) administrations of triptorelin pamoate, 3 months apart).
A Phase II, single-arm clinical trial of administration of cisplatin and 5-fluorouracil with afatinib as first-line therapy in patients with inoperable gastric or gastroesophageal junction cancer
Oct 2012The primary objective of this study is to evaluate the activity of the combination mCisFU-A (modified cisplatin, 5FU, afatinib) in patients with inoperable, locally advanced or metastatic gastric or gastroesophageal adenocarcinoma in terms of objective response, in accordance with RECIST 1.1.
A Randomized, Double-blind, Comparative Study of ZYTIGA (Abiraterone Acetate) Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Oct 2012To determine whether ZYTIGA in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.
I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer (CLERAD-PROBE)
Oct 2012This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.
An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)
Oct 2012To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission
Clinica trial PHASE I-II of LEDC (Liposomal Encapsulated Doxorubicin Cytrate, Myocet®) + CARBOPLATIN IN EPITHELIAL ginecological CANCER
Oct 2012Phase I (Dose escalation) To determine the maximum-tolerated dose (MTD) and recommended phase II dose of the combination of Carboplatin + Myocet every three weeks Phase II (Expansion) To evaluate the activity (objective responses) of the combination of Carboplatin+Myocet every 3weeks in patients with PS and PPS relapse.
A randomized Phase II multicenter, Open Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination with the EOX (Epirubicin, Oxaliplatin, Capecitabine) regimen (plus Zoledronic acid/Interleukin-2) as First-Line Treatment of Patients with CLDN18.2-positive advanced Adenocarcinomas of the Stomach, the esophagus or the gastroesophageal junction. (FAST)
Sep 2012• Progression-free survival (PFS) • Safety and tolerability of IMAB362 in combination with EOX and in case arm 3 is activated with ZA and IL-2
Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation.
Sep 2012To assess disease progression-free interval after surgery combined with intraperitoneal chemo-hyperthermia with respect to the exclusive secondary cytoreduction.
A randomized Phase II multicenter, Open Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination with the EOX (Epirubicin, Oxaliplatin, Capecitabine) regimen (plus Zoledronic acid/Interleukin-2) as First-Line Treatment of Patients with CLDN18.2-positive advanced Adenocarcinomas of the Stomach, the esophagus or the gastroesophageal junction. (FAST)
Sep 2012• Progression-free survival (PFS) • Safety and tolerability of IMAB362 in combination with EOX and in case arm 3 is activated with ZA and IL-2
A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma
Sep 2012The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.
MicroBubble detection and Ultrasound guided Biopsy of axillary Lymph nodes in patients with Early breast cancer.
Sep 2012To see if using an ultrasound visible "dye" (microbubble) to detect the sentinel lymph node draining the breast and to comprehensively biopsy the node once identified can significantly improve the pre-operative diagnosis of axillary (armpit) lymph gland (node) cancer deposits in patients with breast cancer.
Significance of COX-2 inhibition in first line treatment of extensive disease small-cell lung cancer (ED-SCLC)
Sep 2012Investigate the efficacy of combination of celecoxib and standard chemotherapy as first line treatment for ED-SCLC
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)
Sep 2012This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus (NEORAD)
Sep 2012A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
A randomized phase II trial comparing bevacizumab monotherapy with dacarbazine (DTIC) in treatment of malignant melanoma, focusing on angiogenic markers and prevention of hypertension.
Sep 2012The primary objective of this trial is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic or unresectable malignant melanoma.
Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (FOLAGLI)
Sep 2012O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.
Sparing of Organs at Risk in High Dose Rate Brachytherapy
Sep 2012Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative. In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk. The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments. This study will evaluate the feasability and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.
Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients
Sep 20121. Significant increase in the systemic anti-tumor immune response (evaluated as IFN gamma Elispost in response to autologous melanoma cells or HLA-compatible antigenic peptides and phenotypic profile leukocyte, including of immunosoppressorie subpopulations immunosoppressorie as Treg and MDSC) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Increase of pathological tumor response and of the anti-tumor immune infiltrate T, possibly associated with a decrease of negative regulatory cells (Treg and MDSC) in ECT treated lesions, in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment
A Randomised, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer
Aug 2012(1) To evaluate the effect of MK-1775 in combination with paclitaxel + carboplatin compared with placebo in combination with paclitaxel + carboplatin on progression free survival (PFS) per enhanced Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 in patients with platinum sensitive p53 mutant ovarian cancer. (2) To determine the safety and tolerability of MK-1775 in combination with paclitaxel + carboplatin in patients with platinum sensitive p53 mutant ovarian cancer.
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas
Aug 2012To assess the potential for interference of Gemcitabine on immune response to TG01 as determined by TG01 specific DTH skin test reaction and T-cell function in peripheral blood in patients receiving TG01 and GM-CSF after primary resection of pancreatic adenocarcinoma
A safety and efficacy study of adding low dose pegylated ifn-alpha 2b to standard dose dasatinib in patients with newly diagnosed chronic myeloid leukemia
Aug 2012Observe toxicity of drug combination (see protocol) Observe effect measured as response by molecular assessment of BCR-ABL transcript fraction in so called major molecular remission (i.e 3 long below debut levels)
Treatment of TA Bladder cancer with high risk of recurrence – fluorescence cystoscopy with optimized adjuvant mitomycin-c
Aug 20121) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences. 2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib
Aug 2012The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100
Aug 2012The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.
A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy
Aug 2012To estimate the efficacy of BEZ235 in adult patients with advanced (unresectable or metastatic) pNET (PFS)
A randomized phase II study to explore the efficacy and feasibility of upfront rotations between sunitinib and everolimus versus sequential treatment of first line sunitinib and second line everolimus until progression in patients with metastatic clear cell renal cancer.
Aug 2012Progression-free survival (PFS)
Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy (ERRICC)
Aug 2012The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.
A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor
Aug 2012Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.
Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors
Aug 2012To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.
A Multicenter, Phase II, Single-Arm Clinical Trial of nab-Paclitaxel as salvage treatment for patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction
Aug 2012To evaluate the objective response (CR and PR) rates of nab-Paclitaxel as salvage treatment in patients with metastatic/locally advanced gastric or GEJ cancer previously treated with DCF.
Phase II study of cabazitaxel as 2nd-line treatment in patients with HER-2 negative metastatic breast cancer previously treated with taxanes
Aug 2012The primary objective is to assess the clinical activity of cabazitaxel regarding the objective response rate (ORR).
Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
Aug 2012The objective of this study is to evaluate the efficacy and safety of BAY 80 6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy.
A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma
Aug 2012To compare the efficacy and tollerability of two chemotherapeutic regimens (either Cyclophosphamide+ Etoposide or high dose Ifosfamide) currently used to treat relapsed Osteosarcoma patients
Efficacy and feasibility of first-line treatment with risk-adapted dose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkitt lymphoma. A phase II clinical trial.
Aug 2012• Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years. • Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an outpatient-clinic basis
A second-line, single arm, phase II clinical study with tremelimumab, a fully humanized anti-CTLA-4 monoclonal antibody, as monotherapy in patients with unresectable malignant mesothelioma
Aug 2012To assess the rate of objective clinical complete response (CR) or partial response (PR)
A Phase II Study to evaluate activity and toxicity of Gemcitabine in Combination with Pemetrexed long term infusion in the Treatment of pretreated Metastatic Colorectal Cancer Patients
Aug 2012The primary objective of the study is to determine the objective response rate (ORR: CR+PR+SD)
A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment. The ReCab trial
Aug 2012To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.
A phase II, multicenter, open-label, randomized study evaluating the efficacy and safety of folfiri + MEHD7945QA versus folfiri + cetuximab in second line in patients with KRAS wild-type metastatic colorectal cancer
Jul 20121-To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC 2- To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC whose tumors express low levels of HER3
BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
Jul 2012The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (breast cancer, Hodgkin's lymphoma).
A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancer
Jul 2012The primary objective of the study is to determine whether a 40mg twice daily dose of AZD8931 administered for 10-14 days (up to 18 days if surgery recheduled) results in suppression of cancer cell growth, by looking at changes in a marker called Ki67, which represents proliferation of tumour cells, before and after treatment with AZD8931.
Cabazitaxel in platinum refractory ovarian cancer. A phase II trial
Jul 2012To investigate the response rate of cabazitaxel in platinum refractory, ovarian cancer.
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)
Jul 2012The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
A Phase IIa Exploratory Study of OCZ103-OS in Combination with Platinum-Gemcitabine based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients
Jul 2012To obtain a preliminary evidence of the clinical efficacy of OCZ103-OS used in combination with platinum-gemcitabine based doublet first line therapy in adult NSCLC patients, by assessing primarily Overall Response Rate (ORR), as well as Duration of Response (DR), Progression Free Survival (PFS), Overall Survival (OS), Time to progression (TP) and Time to Distant Metastasis (TDM)
A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advanced Hepatocellular Carcinoma (HCC).
Jul 2012Determine radiographic response rate (based on mRECIST for HCC and mChoi criteria).
A Phase 2b Randomized Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment.
Jul 2012Determine and compare overall survival for patients receiving JX-594 plus best supportive care (BSC) (Arm A) versus those receiving BSC (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.
Jul 2012Efficacy of L19IL2/L19TNF-treated lesions measured as : Rate of patients with complete response (CR) of L19IL2/L19TNF-treated lesions at week 12 (day 85).
A randomised Phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium
Jul 2012Phase II part: -efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU. Phase III part: -efficacy of cabazitaxel compared to vinflunine in terms of improved OS of subjects with metastatic or locally advanced, previously treated TCCU.
Neurotoxicity characterization phase II randomized study of nab-paclitaxel versus conventional paclitaxel as first-line therapy of metastatic HER2-negative breast cancer.
Jul 2012To characterize neurotoxicity according to Total Neuropathy Score
Phase Ib dose finding study of abiraterone acetate plus BEZ235 or BKM120 in patients with castration-resistant prostate cancer
Jul 2012Dose escalation part: Define maximum tolerated dose (MTD) and /or recommended dose for expansion (RDE) of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1. Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment Prostate specific antigen (PSA) progression according to prostate cancer working group 2 criteria (PCWG2) by assessing PSA decline ? 30% at Week 12 or later.
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Jul 2012This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support
A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0
Jul 2012The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.
An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) Pharmacogenetics Blood Sample Protocol Amendment 01 version 1.0 dated 12-Jun-12
Jul 2012The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy
A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Jul 2012To compare the therapeutic efficacy of Docetaxel, Oxaliplatin and Capecitabine (low-TOX) vs. Epirubicin, Oxaliplatin and Capecitabine (EOX) as measured by the duration of overall survival (OS) in patient with locally advanced/metastatic gastric cancer.
Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Jul 2012To determine the tumor antigen-specific immune response induced by the treatment and to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Jul 2012To determine the tumor antigen-specific immune response induced by the treatment 2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Jul 2012To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
Open-Label, Phase II Study of Trastuzumab in Combination with Lapatinib or Pertuzumab in Combination with Trastuzumab in Patients with HER2-positive Metastatic Colorectal Cancer: the HERACLES Trial (HER2 Amplification for Colo-rectaL Cancer Enhanced Stratification)
Jul 2012Define the antitumor activity of the anti-HER2 combinations of lapatinib + trastuzumab and pertuzumab + trastuzumab given to two separate, sequential cohorts of patients with chemo-refractory advanced disease and HER2 amplified tumours.
Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer
Jul 2012This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.
A prospective randomized phase II trial of FOLFIRINOX, and radiation therapy versus FOLFIRINOX alone in patients with locally advanced pancreatic cancer that cannot be removed by surgery
Jul 2012R0 resection rate
The Head and Neck TUMOR Biobank
Jul 2012The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.
Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia
Jul 2012To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.
A randomized, phase III, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of onartuzumab (metmab) in combination with 5-fluorouracil, folinic acid, and oxaliplatin (MFOLFOX6) in patients with metastatic HER2-negative, MET-positive gastroesophageal cancer
Jul 2012• To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by overall survival (OS) in patients with previously untreated HER2–negative metastatic gastroesophageal cancer (GEC) classified as Met IHC 2+ or 3+ (Met 2+/3+ subgroup) • To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by OS in patients with previously untreated HER2 negative metastatic GEC classified as Met-IHC 1+, 2+, or 3+ (intent-to-treat [ITT] population)
An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutations
Jul 2012To determine progression free survival (PFS) of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation, treated with the combination of erlotinib and bevacizumab. Hypotheses of interest: When treated with bevacizumab and erlotinib a. Median PFS increases to 18 months for patients with EGFR T790M mutation b. Median PFS is approximately 18 months or more in patients without EGFR T790M mutation.
NOA-12: BIBF1120 and R-RT in Glioblastoma
Jul 2012Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.
An Open-Label Phase I/II Study of GSK2110183 in Combination with Carboplatin and Paclitaxel in Subjects with Platinum-Resistant Ovarian Cancer
Jul 2012Primary Phase I To determine the safety and tolerability of GSK2110183 administered in combination with carboplatin and paclitaxel in subjects with ovarian cancer--which will be used to identify the dosing regimen to be evaluated in Phase II. Primary Phase II To evaluate the clinical efficacy (as measured by overall response rate) of GSK2110183 administered in combination with carboplatin and paclitaxel in subjects with recurrent platinum-resistant ovarian cancer.
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)
Jul 2012To examine the effect on one year survival of giving hydroxychloroquine (HCQ) with short course radiotherapy (SCRT) to high grade gliomas (HGG) patients aged ≥ 70 years
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A single arm Pharmacokinetic/Pharmacodynamic Study of Sunitinib in Patients with Metastasized Renal Cell Carcinoma
Jul 2012Develop PK/PD models for sunitinib including biomarker response (blood pressure, sVEGFR-2, sVEGFR-3) as PD marker
A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)
Jul 2012The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort
A two-part, randomized Phase II, double-blind, multicenter trial assessing the efficacy and safety of pertuzumab in combination with standard chemotherapy vs. placebo plus standard chemotherapy in women with recurrent platinum resistant epithelial ovarian cancer and low HER3 mRNA expression
Jul 2012Part 1: Safety Run-in Phase The primary objective for Part 1 of this study is as follows: -To determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel. Part 2: The primary objective for Part 2 of this study is as follows: -To determine if pertuzumab plus chemotherapy is superior to placebo plus chemotherapy as measured by progression-free survival (PFS).
Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)
Jul 2012Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
Study of a Predictor for Cervix Cancer (ANOXICOL)
Jul 2012Non operated cervix cancer (diameter > 4 cm) and stade Ib2-IIb are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures. Persistence of tumor hypoxia could be a predictive factor of local control
Treatment of Cancer in the head and Neck: The Role of Hyperbaric Oxygen in Reducing Swallowing Problems
Jun 2012Potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck
Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma
Jun 2012To assess the antitumor activity of CAP7.1 based on the observed objective rersponse rate and rate of disease stabilization using Recist.
Phase II study of irinotecan weekly in combination with trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1
Jun 2012Response rate according to RECIST 1.1
Randomized, double-blind, phase 3 study of TAS-102 plus best supportive care (bsc) versus placebo plus bsc in patients with metastatic colorectal cancer refractory to standard chemotherapies
Jun 2012To compare the following endpoints for the TAS-102 (experimental) arm with the placebo (control) arm in patients with refractory metastatic colorectal cancer: Overall survival (OS) Progression-free survival (PFS) Safety and tolerability
A Phase I / II Dose Escalation and Randomised Controlled Trial of ColoAd1 Administered by Sub-acute Fractionated Intravenous Injection to Patients with Metastatic Colorectal Cancer
Jun 2012Phase I: - To evaluate the safety and tolerability of ColoAd1, when administered by sub-acute fractionated IV injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists - To determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated intravenous (IV) injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists, and to recommend a dose for phase II studies. Phase II: - To evaluate the progression free survival (PFS) in patients with metastatic colorectal cancer, who receive ColoAd1 administered by sub-acute fractionated IV injection as an intensification of first line chemotherapy compared with first line chemotherapy alone.
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Jun 2012Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma.
Jun 2012To compare the activity of carfilzomib in combination with cyclophosphamide and low dose dexamethasone (CCD) to that of the control treatment of bortezomib, cyclophosphamide and dexamethasone (CVD) in patients with multiple myeloma at first relapse. Specifically the study will assess whether CVD provides non-inferior activity with regard to the short-term outcome measure of ≥Very Good Partial Response rates at 24 weeks, and superior activity in terms of the longer-term outcome measure of progression-free survival.
Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients with Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer with Negative or Unknown BRCA Status
Jun 2012Phase I: To determine: Maximum-tolerated dose (MTD) Dose-limiting toxicities (DLT) Recommended phase II dose Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status.
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Jun 2012The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
The use of Tachosil as sealant in the prevention of lymphorrea after groin lymphadenectomy for vulvar cancer: a clinical controlled prospective trial
Jun 2012Reduction of grade 2 and grade 3 lymphedema incidence 3 months after the surgery in patients treated with TachoSil after groin Lymphadenectomy for vulvar cancer
Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer (POWER)
Jun 2012The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over 5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.
A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology
Jun 2012. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
Jun 2012The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.
Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The "RED-GREEN-BLUE" melanoma study.
Jun 2012The principal research question is to assess the sensitivity of indocyanine green (ICG) for Sentinel lymph node detection in cutaneous melanoma in combination with technetium radioisotope and patent blue dye.
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
Jun 2012To assess acute and long-term safety and overall survival in patients with castration-resistant (hormone-refractory) prostate cancer.
MRI-perfusion and FLT- and FET-PET during bevacizumab monotherapy for patients with recurrent Glioblastoma Multiforme
Jun 2012Determine changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET
A phase III randomized, double-blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.
Jun 2012To assess the treatment effect of BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant on progression-free survival (PFS)
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis
Jun 2012Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis To assess acute and long-term safety of radium-223 chloride
A phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum based chemotherapy
Jun 2012This is a phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. The main objective is to evaluate the efficacy of MEHD7945A (administered every 2 weeks) versus cetuximab (administered weekly) in all and in biomarker positive patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), as measured by progression-free survival (PFS).
A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)
Jun 2012Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC
A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients
Jun 2012The primary objective of this trial is to assess the activity - in terms of percentage of CR - of Clofarabine in combination with Cyclophosphamide in adult patients with refractory and relapsed (≤24 months from first CR) ALL.
A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neck
Jun 2012The aim of the study is to determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity, and evaluate the tolerance, compliance and toxicity of using nimorazole
A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen
Jun 2012To evaluate the safety of aflibercept in patients with metastatic Colorectal Cancer (mCRC) treated with irinotecan/5FU combination (FOLFIRI) after failure of an oxaliplatin based regimen (patients similar to those evaluated in the VELOUR trial)
Phase I Hybrid study: combined stereotactic radiotherapy and conventional fractionation in stage II and III non small cell lung cancer with peripheral tumors smaller than 5 cm
Jun 2012To define the recommended phase II mean-lung dose (MLD) to treat peripheral stage II or III non small cell lung cancer (NSCLC) using stereotactic ablative radiotherapy (SABR) for the primary tumor and conventional fractionated radiotherapy (CFRT) for the mediastinal lymph nodes while given concurrent chemotherapy
A randomized phase II trial comparing pazopanib with doxorubicin as first line treatment in elderly patients with metastatic or advanced soft tissue sarcoma
Jun 2012To show that progression-free survival in the pazopanib group is not inferior to that in the doxorubicin group
Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
Jun 2012This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.
Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell lung cancer (NSCLC)
Jun 2012To evaluate and compare objective response rates in both arms while defining toxicity profiles of both application schedules. Additionally, evaluation of biologically validated, potentially predictive biomarkers and identification of new biomarkers for therapy response, therapy resistance, and course of disease in formalin-fixed paraffin-embedded (FFPE) and fresh tumour specimens as well as circulating tumour cells (CTCs), obtained before treatment and, if applicable, during and after study treatment.
Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET.
Jun 2012The study will primarily assess the efficacy of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.
A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
May 2012The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.
Use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms
May 2012To evaluate diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 immunochemical Fecal Occult Blood Tests (iFOBTs) for detecting advanced colorectal neoplasms after a single dose of acetylsalicylic acid as compared to placebo
A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer. Protocol Amendment 01-Pharmacogenetics Blood Sample Amendment (dated 12-Jan-2012), site specific, and administrative letter 01dated 07-Feb-2012 Protocol Amendment 02: Biomarker substudy (dated 12-Jan-2012), site specific
May 2012The purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients
May 2012During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of panobinostat, administered in combination with VTD, in subjects with relapsed and relapsed/refractory multiple myeloma. In the dose expansion phase the purpose of the study is to estimate the response rate (partial response or better) within 16 cycles of VTD-pano at the RD identified in the dose escalation phase.
Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy.
May 2012Co-primary objectives are: 1. To evaluate the rate of MMR at 18 months of nilotinib 300 mg BID monotherapy vs. nilotinib 300 mg BID + pegylated interferon alpha (Peginterferon alpha-2b) 2. To evaluate the rate of continuous MMR after discontinuation of nilotinib vs. interferon alpha.
Adjuvant PEG Intron in Ulcerated Melanoma
May 2012The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma
May 2012The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
May 2012The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
May 2012This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer. Protocol Amendment 01-Pharmacogenetics Blood Sample Amendment (dated 12-Jan-2012), site specific, and administrative letter 01dated 07-Feb-2012 Protocol Amendment 02: Biomarker substudy (dated 12-Jan-2012), site specific
May 2012The purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
May 2012This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared with paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer
May 2012To evaluate the efficacy of bevacizumab + paclitaxel compared with placebo + paclitaxel as first-line treatment in patients with HER2-negative metastatic breast cancer as measured by: - PFS based on investigator tumor assessment in the intent-to treat (ITT) patient population - PFS based on investigator tumor assessment in ITT patients with high plasma VEGF-A levels
A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC
May 2012This study tests the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line NSCLC in participants with all target lesions expressing the folate receptor [FR(++)]. Primary objective: progression free survival (PFS)
Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Relapsed Acute Myeloid Leukaemia ineligible for Intensive Chemotherapy
May 2012To evaluate the activity of azacitidine and vorinostat combined therapy, in terms of overall response (OR) (complete remission (CR), complete remission with incomplete blood count recovery (CRi) and partial remission (PR), as defined by Cheson criteria) and overall survival (OS) in patients with relapsed AML who are ineligible for intensive chemotherapy.
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
May 2012The primary objectives are to evaluate the rate of Grade 2 or higher QTcF prolongation and to evaluate the composite complete remission rate (CRc), defined as the confirmed rate of complete remission (CR) plus complete remission with incomplete platelet recovery (CRp) or incomplete hematological recovery (CRi) at different doses of AC220.
A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone
May 2012Part A: • To assess the safety and tolerability (incidence and severity of adverse events [AEs]) of the combination of AT13387 and abiraterone acetate and to select the most promising treatment regimen for the combination in subjects with castration-resistant prostate cancer (CRPC) who are no longer responding to treatment with abiraterone acetate alone, based on the overall assessment of safety and antitumor activity. Part B: • To assess and compare the antitumor activity (response rate per the Prostate Cancer Working Group 2 [PCWG2] recommendations) between single-agent AT13387 and the combination of AT13387 plus abiraterone acetate in subjects who are no longer responding to treatment with abiraterone acetate alone.
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer
May 2012To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm
A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancer
May 2012The objective of this study is to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone.
Safety and efficacy of intramuscular electrotransfer of plasmid AMEP in patients suffering from advanced or metastatic melanoma: an open-label phase I/II clinical trial the AIMM Study (AMEP in metastatic melanoma)
May 2012Part 1: Phase I Patients with advanced or metastatic melanoma will receive intramuscularly increasing doses of plasmid AMEP Primary objective: - To determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. Part 2: Extension Phase I/II Patients with advanced or metastatic melanoma will receive intramuscularly the recommended dose of plasmid AMEP either alone or in combination with dacarbazine Primary objective: - To confirm the safety and tolerability of intramuscular electrotransferred Plasmid AMEP at the established recommended dose, alone or in combination.
A randomized phase II study of Bevacizumab/mFOLFOX6 vs. Bevacizumab/FOLFIRI with biomarker stratification in patients with previously untreated metastatic colorectal cancer
May 2012To assess whether: • Expression of chemotherapy resistance marker ERCC-1 is associated with progression-free survival (PFS) in first-line metastatic colorectal cancer (CRC) patients treated with bevacizumab in combination with mFOLFOX6 or FOLFIRI • Plasma level of vascular endothelial growth factor A (VEGF-A) as a potential biomarker for bevacizumab, and in combination with ERCC-1 expression as a chemotherapy regimen biomarker, is associated with different PFS
A Phase II Randomized Open Label Study of MM-121 in combination with Paclitaxel versus Paclitaxel alone in patient with Platinum Resistant/Refractory Advanced Ovarian Cancers.
May 2012To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents.
A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.
May 2012To assess the treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival (PFS)
A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial
May 2012We intend to assesswhether or not the intraoperative application of two collagen-fibrin patches (Tachosil®) to the obturator fossa and the femoral canal will reduce the number of sonographically detected pelvic lymphoceles by at least 50% (primary study end point) in women with endometrial or cervical cancer undergoing perlvic lymphadenectomy.
A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial
May 2012We intend to assesswhether or not the intraoperative application of two collagen-fibrin patches (Tachosil®) to the obturator fossa and the femoral canal will reduce the number of sonographically detected pelvic lymphoceles by at least 50% (primary study end point) in women with endometrial or cervical cancer undergoing perlvic lymphadenectomy.
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
May 2012The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.
A Study of RO5185426 in Patients With Metastatic Melanoma
May 2012This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin
May 2012Dose Escalation Cohort: To investigate the safety, tolerability and feasibility of the novel AGC (AZD4547 with gemcitabine and cisplatin) combination in advanced non-haematological malignancies. Randomised Expansion Cohort: To obtain a preliminary indication of the relative toxicities of AGC compared to GC in locally-advanced/metastatic TCC of the urinary bladder (and other urothelial) cancers.
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
May 2012To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM)
A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels
May 2012To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino
A Phase II study of the selective BRAF kinase inhibitor GSK2118436 in subjects with advanced non-small cell lung cancer and BRAF mutations
May 2012To assess the overall response rate (ORR) in subjects with stage IV or relapsed BRAF V600E mutant non-small cell lung cancer administered GSK2118436 as a single agent.
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
May 2012This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.
Double blind placebo controlled randomized intervention study aiming at reducing dexamethasone related side effects in children with acute lymphoblastic leukemia (ALL).
May 2012To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.
A Phase I/II Dose Escalation Trial Of HDAC Inhibitor Tefinostat (CHR2845) For Cancer Associated Inflammation In Hepatocellular Carcinoma
May 2012Phase I: To determine the safety, tolerability and dose-limiting toxicities (DLT) of tefinostat when administered orally to patients with advanced HCC To determine the recommended Phase II dose (RP2D) of tefinostat in patients with advanced HCC Phase II: To perform a preliminary assessment of the anti-disease activity of tefinostat as measured by mRECIST.
A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922 in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or - amplification or - mutation.
May 2012To evaluate efficacy of combined trastuzumab and AUY922 in HER2 - overexpressed or - amplified or - mutated NSCLC
An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)
May 2012To compare the hematological remission, defined as CR (both CR and CRi), as reported by the external independent endpoint adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive active comparator (Arm B).
A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy
May 2012Does treatment with axitinib stop previously untreated widespread kidney cancer that can't be surgically removed from getting worse for at least 6 months?
High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency
May 2012This study will investigates the effect of high dose alkylating chemotherapy compared to standard dose chemotherapy as part of a multimodality approach in patients with oligometastatic HRD positive or BRCA1/2 related breast cancer.
A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer.
May 2012The MA.32 study will investigate whether adding 5 years of metformin treatment to standard of care treatment for breast cancer, decreases the likelihood of breast cancer returning.
Lenalidomide and Dexamethasone With/Without Transplant in Patients With Multiple Myeloma
May 2012The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
May 2012The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva
May 2012This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva.
Effects of short-term atorvastatin treatment on prostate cancer - a pre-surgical pilot trial
May 2012Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment.
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The “ACT IV” Study)
May 2012The primary objective of the study is to confirm that the addition of rindopepimut/GM-CSF to adjuvant temozolomide improves overall survival in patients with newly diagnosed, resected, EGFRvIII positive glioblastoma who have undergone gross-total resection.
A phase Ib/II open-label, multi-center study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors
May 2012Phase Ib: Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) by measuring incidence of dose limiting toxicities Phase II: Antitumor activity of MEK162 in combination with AMG 479 by evaluating Objective Response Rate (ORR) in colorectal carcinoma and melanoma and by evaluating Disease Control Rate (DCR) at week 10 in pancreatic carcinoma
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
A perioperative, single-arm multicenter Phase II academic trial to investigate the efficacy and safety of panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI) in patients with previously untreated, wild-type KRAS, potentially resectable colorectal cancer liver metastases
May 2012Objective response rate (ORR) and safety
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
May 2012This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
May 2012To compare progression-free survival (PFS) in patients with multiple myeloma relapsed after 1 to 3 prior therapies treated with either carfilzomib plus dexamethasone (Cd) or bortezomib (Velcade®) plus dexamethasone (Vd).
Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer
May 2012To determine whether treatment with ADI-PEG 20 will shrink small cell lung cancer.
Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)
Apr 2012Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos. Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath. Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.
Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
Apr 2012The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Apr 2012This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Apr 2012To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Apr 2012To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1
A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels
Apr 2012To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino
Diagnosing Thyroid Cancer Using a Blood Test
Apr 2012Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.
A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma
Apr 2012To establish the superiority of dabrafenib and trametinib combination therapy with vemurafenib monotherapy with respect to overall survival (OS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.
FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema
Apr 2012The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.
A randomized, double-blind, placebo-controlled, multicenter phase II study evaluating the efficacy and safety of onartuzumab in combination with bevacizumab or onartuzumab monotherapy in patients with recurrent glioblastoma
Apr 2012• To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed progression-free survival (PFS) • To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed PFS in the subgroup of patients with Met-positive (Met+) glioblastoma
Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)
Apr 2012The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).
MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients
Apr 2012The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.
A Survivorship Care Plan for Gynaecological Cancer Patients
Apr 2012The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life.
A Phase 3bMulticenter, Open-label Abiraterone Acetate Long-term Safety Study
Apr 2012To collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.
A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer
Apr 2012To assess the antitumor activity of TKI258, as measured by an 18-week progression free survival (PFS) rate, in patients with pre-treated endometrial cancer, with or without FGFR2 mutation.
Phase II multicenter single-arm study evaluating the safety and efficacy of everolimus as a first-line treatment in newly-diagnosed patients with advanced GI neuroendocrine tumors.
Apr 2012To evaluate 15month progression-free survival rate (15month PFS rate) (according to RECIST 1.1) in newly-diagnosed patients with advanced or unresectable GI and pancreatic neuroendocrine tumors treated with everolimus as a first-line treatment.
Individualised first line chemotherapy in metastatic colo-rectal cancer (mCRC). Is plasma TIMP-1 a predictive factor for best choise of first line chemotherapy in mCRC?
Apr 2012Aim is to investigate whether or not the cancer marker plasma TIMP-1 is related to probability of treatment response on chemotherapy with or without irinotecan
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) Revised Protocol 01 incorporating administrative letter 04 and protocol amendment 04 (dated 09-Feb-2012)
Apr 2012To compare overall survival (OS) of subjects randomized to ipilimumab in addition to platinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum and etoposide (Arm B) in subjects with newly diagnosed extensive stage SCLC.
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Apr 2012The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
Phase II multicentric and prospective trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma
Apr 2012Analyze progression free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.
New Adjuvant Chemotherapy of Non Resectable Liver Metastasis of Colorectal Cancer Without Bleeding, Obstruction
Apr 2012Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal cancer without bleeding, obstruction, etc.
Adjuvant phase III trial to compare intense dose-dense adjuvant treatment with EnPC to dose dense, tailored therapy with dtEC-dtD for patients with high-risk early breast cancer
Apr 2012Comparison of disease-free survival
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Apr 2012The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma
Apr 2012To establish the superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.
A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Apr 2012To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer
Apr 2012This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Apr 2012The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.
Molecular Analysis of Retinoblastoma
Apr 2012The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
Apr 2012To evaluate the effects of orteronel, when administered with prednisone, on the QT/QTc interval in patients with metastatic castration-resistant prostate cancer (mCRPC)
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Apr 2012Phase 1 part: To evaluate the safety and tolerability of S-488210 in HLA A*02:01-positive patients with head and neck squamous cell carcinoma (HNSCC) receiving 4 vaccinations of S-488210 Phase 2 part: To compare the overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients receiving S-488210
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Apr 2012This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
Apr 2012This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.
Molecular Biomarkers for Colorectal Liver Metastases Resectability after Chemotherapy with Cetuximab
Apr 2012Complete liver resection after chemotherapy
A randomized phase III trial comparing nanoparticle-based paclitaxel with solvent-based paclitaxel as part of neoadjuvant chemotherapy for patients with early breast cancer (GeparSepto)
Apr 2012To compare the pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.
Multicenter phase 1/2a study using T-cell receptor gene therapy in metastatic melanoma
Apr 2012To study the efficacy of this treatment strategy in inducing tumor-specific T cell immunity as measured by the presence of Mart-1 specific T cells in peripheral blood samples on several time points following adoptive transfer.
A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 2/3 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma
Apr 2012The primary objective of Phase 2 is to select a dose of LY2127399 to assess with bortezomib and dexamethasone in Phase 3. The primary objective of Phase 3 is to compare PFS after treatment with the dose of LY2127399 selected in Phase 2, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.
A phase II window-of-opportunity study of preoperative therapy with pazopanib (votrient®) in high-risk soft tissue sarcoma
Apr 2012To evaluate whether neoadjuvant treatment with pazopanib in patients with soft-tissue sarcoma has therapeutic effects, measured as metabolic response.
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Apr 2012The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors
Apr 2012The purpose of this study is to compare the uses of two types of equipment during transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These two devices do the same task but differ in the way they create electric current when removing cancerous tissue. The investigators hope to examine and compare the uses of these two surgical devices to see if any advantages do exist or whether they actually are similar. The goal of the study will be to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic Melanoma Revised Protocol 02 incorporating Protocol Amendments 05 and 09 + Pharmacogenetics Blood Sample Amendment- Site Specific (version 1.0 dated 10-Nov-11) + Protocol Amendment 03- Site Specific (version 1.0 dated 09-nov-2011) + Protocol Amendment 07- Site Specific (version 1.0 dated 21-mar-2012) + Biomarker Sub-Study Protocol amendment 06 version 1.0, dated 29-May-2012- Site-specific
Mar 2012The purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg
NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer
Mar 2012To compare overall survival following treatment with MM-398 versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine based therapy.
An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer
Mar 2012The purpose of the study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Sipuleucel-T (Provenge®) is approved for use in the US by the Food and Drug Administration for the treatment of metastatic castrate resistant prostate cancer. The study sponsor, Dendreon Corporation is applying for Manufacturing Authorization in Europe. The intent of this study is to demonstrate that sipuleucel-T manufactured in Europe results in the same cellular activation as seen in sipuleucel-T produced in the US.
An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Mar 2012To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine
Mar 2012To compare the Overall Survival (OS) of patients who receive NKTR-102 given once every 21 days to patients who receive TPC selected from the following list of seven single-agent intravenous therapies: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel or nab-paclitaxel.
A Phase IIIB, Multi-Center, Open Label Study For Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) in Combination With Exemestane
Mar 2012To assess the Overall Response Rate (ORR) in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with NSAIs treated with the combination of Everolimus and Exemestane.
An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Mar 2012To provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and to assess the safety of regorafenib
Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage
Mar 2012For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the Reese-Ellsworth classification) in which enucleation would usually be the standard therapeutic approach, in this project the investigators propose an alternative conservative treatment using intra-arterial chemotherapy with melphalan, via direct administration by catheterization of the ophthalmic artery.
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Mar 2012The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects.
A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)
Mar 2012This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.
A randomized study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer.
Mar 2012To determine the predictive value of median Cetuximab uptake for response to concomitant Cisplatinum or Cetixumab together with radiation
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Mar 2012This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma
Mar 2012The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.
A Phase II study of neoadjuvant chemotherapy given before SCPRT as treatment for patients with MRI-staged operable rectal cancer at high risk of metastatic relapse
Mar 2012The principal reasearch question is whether in MRI-defined operable rectal cancer patients, it is feasible to treat for eight weeks with oxaliplatin/5-Fluorouracil chemotherapy and then give a short course of preoperative radiotherapy (SCPRT)immediately before surgical removal of the tumour. This will be measured by calculating the proportion of patients successfully completing surgery.
Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma A Multi-Institutional Cross-Discipline Non-Therapeutic Study
Mar 2012To evaluate the effect of gender on the pharmacokinetics (PK) of doxorubicin in AYA* patients with newly diagnosed: -Ewing family of tumours (EFT)** -Osteosarcoma (OS); or -Hodgkin lymphoma (HL) *AYA is defined as young people who have entered puberty (Tanner stage ≥2) or are pubertally mature, regardless of whether they are being treated on an adult chemotherapy regimen or a children’s chemotherapy regimen. **EFT includes Ewing’s sarcoma of bone, extra-osseous Ewing Sarcoma, and PNET (primitive neuroectodermal tumour) outside the central nervous system.
Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors
Mar 2012This phase II trial studies how well linsitinib works in treating younger and adult patients with gastrointestinal stromal tumors.
Randomized double-blind placebo controlled Phase II study to evaluate the efficacy and safety of Sorafenib treatment in patients with advanced (recurrent, persistent and/or metastasizing) medullary thyroid carcinoma (SUMMIT).
Mar 2012The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
Mar 2012In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.
A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum as first-line treatment in patients with stage IIIb or IV Non-Squamous Non−Small Cell Lung Cancer (NSCLC)
Mar 2012To evaluate the efficacy of MetMAb compared with placebo by PFS in all patients and in the subgroup of patients with Met diagnostic–positive tumors in each of two combination treatment cohorts: Cohort 1: MetMAb + bevacizumab + platinum + paclitaxel vs. placebo + bevacizumab + platinum + paclitaxel Cohort 2: MetMAb + platinum + pemetrexed vs. placebo + platinum + pemetrexed
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
Mar 2012The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.
Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
Mar 2012To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and CEA) and in tumor-related diarrhea. To determine the safety and tolerability of Vandetanib in children and adolescents. To study how the body handles Vandetanib in children and adolescents. To determine the effect of Vandetanib on the survival of children and adolescents with MTC.
A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy
Mar 2012To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer
Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer
Mar 2012Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.
To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer.
Mar 2012To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer 1. Identification of one or more inguinofemoral lymph nodes 2. Correct intraoperative identification of the sentinel node as verified by Technetium 99m & patent blue dye
TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.
Mar 2012The primary objective of this study is to evaluate the activity of olaparib in patients with advanced prostate cancer who have progressed following one or two chemotherapy regimens including docetaxel.
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer.
Mar 2012The primary objective of this study is to compare the efficacy of palifosfamide-tris in combination with carboplatin and etoposide (PaCE) chemotherapy to carboplatin and etoposide (CE) alone, as measured by overall survival (OS), in chemotherapy naïve subjects with extensive-stage SCLC.
Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.
Mar 2012To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite
A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with paclitaxel + cisplatin or carboplatin as first-line treatment for patients with stage IIIb (T4 disease) or IV squamous non-small cell lung cancer (NSCLC)
Mar 2012To evaluate the duration of progression-free survival of MetMAb + paclitaxel + platinum (cisplatin or carboplatin) relative to placebo + paclitaxel + platinum in all enrolled patients and in the subgroup of patients with Met diagnostic–positive tumors
A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non- Small Cell Lung Cancer (NSCLC) and who previously responded to gefitinib and received subsequent chemotherapy or other active anti-cancer therapy excluding EGFR-TKIs
Mar 2012To characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC
Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.
Mar 2012To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite
Randomized Phase II Study of Cabazitaxel versus Topotecan in Small Cell Lung Cancer Patients with Progressive Disease during or after a First Line Platinum Based Chemotherapy
Mar 2012To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
Phase II study on ET-743 in BRCA1 and BRCA2 mutation carrie and BRCAness phenotype advanced ovarian cancer patients.
Mar 2012To determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.
An Open Label Phase II Study on the Use of Panobinostat in Combination with Bortezomib and Dexamethasone as Induction in Multiple Myeloma Patients Candidate to High-Dose Therapy
Mar 2012To evaluate if the combination of Panobinostat, Bortezomib and high-dose Dexamethasone as induction therapy can increase the complete response (CR) rate in subjects with previously untreated multiple myeloma who are candidates to autologous stem cell transplantation (ASCT).
CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy
Mar 2012This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
Mar 2012To determine the best tolerated and effective dose (dose finding) for oral Lenalidomide among 10, 15, 20 e 25 mg dose levels in a 28-day cycle, as associated to a fixed dose of weekly bendamustine (60 mg/m2 on days 1, 8 and 15), based on the best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook in subjects with Recurrent Hodgkin Lymphoma
An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Mar 2012The main objectives of this study are (I) to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and (II) to assess the safety of regorafenib
Prospective study of 18F-RGD PET-CT in assessment of response to antiangiogenic treatment in patients with renal cancer and comparison with perfusion CT
Feb 2012To evaluate whether changes of uptake on 18F-RGD PET-CT before, during and after anti-angiogenic therapy are associated with tumour response in patients with cancer.
Magnetic resonance with gadoxetic acid for the diagnosis of hepatocellular carcinoma in patients with liver cirrhosis. Evaluation of its impact for the non-invasive diagnosis.
Feb 2012To establish the diagnostic accuracy of magnetic resonance imaging with gadoxetate disodium for the diagnosis of hepatocellular carcinoma that do not fulfil the established diagnostic criteria as per current guidelines of AASLD (American Association for the Study of Liver Diseases)
Phase 2a Single-Arm Safety Study of Elotuzumab in Combination with Thalidomide and Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma
Feb 2012To determine the safety and tolerability of Thalidomide-dexamethasone-Elotuzumab (TdE) in subjects with relapsed and/or refractory MM as assessed by the incidence of severe (Grade 3 or higher) non-hematologic adverse events (AEs).
A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38MAPK Inhibitor, plus Gemcitabine and Carboplatin versus Gemcitabine and Carboplatin for Women with Platinum-Sensitive Ovarian Cancer
Feb 2012Phase 1b - to determine the recommended Phase 2 dose of LY2228820 that can be safely administered with gemcitabine and carboplatin Phase 2 - to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin
Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer
Feb 2012This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).
Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer
Feb 2012For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.
Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy (FOThyr)
Feb 2012The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.
Feb 2012To determine the effect of chemotherapy in breast cancer patients with lymph node that do not have the Recurrence Score (RS) high by Oncotype DX® test.
A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Feb 20121. To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherpapy permitted) compared with doxorubicin alone 2. To assess the safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone
A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)
Feb 2012The primary objective is to compare survival rate at 12 months in Vx-001 treated vs placebo treated patients.
An Open-label, Multicenter Phase 1/2 Study of JNJ-40346527, a FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin’s Lymphoma
Feb 2012Phase 1: To establish the recommended Phase 2 dose for JNJ-40346527. Phase 2: To determine the overall response rate (complete response [CR] + partial response [PR]) in subjects with relapsed or refractory cHL.
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
Feb 2012The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.
Effect of oral administration of red clover on menopausal symptoms of the syndrome induced by adjuvant hormonal treatment in women diagnosed with breast cancer
Feb 2012Decrease of menapausal symptoms in women treated with tamoxifen for breast cancer after surgery
A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neoadjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
Feb 2012To record the proportion of patients whose cancer responds to chemotherapy using the drugs cabazitaxel and cisplatin before surgery in the treatment of transitional cell carcinoma of the urinary bladder. This small study of about 30 patients will help to establish whether this treatment should be studied further in a larger group of patients in future.
Application of High Resolution Diffusion-Weighted MR Imaging Plus Sequence in Head and Neck Cancer
Feb 2012Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.
A phase IV, multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of Sorafenib in patients with hepatocellular carcinoma after radiological progression
Feb 2012To determine efficacy of Sorafenib in advanced hepatocellular carcinoma (stage C of BCLC classification) after radiological progression.
Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery
Feb 2012This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery.
A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.
Feb 2012To assess the antitumor activity of PM01183 in terms of overall response rate (ORR) according to RECIST vs 1.1 in each cohort of metastatic breast cancer (MBC) patients.
CANVAS: A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-Line Chemotherapy
Feb 2012To assess the efficacy, in terms of progression-free survival (PFS), of Cvac as compared with placebo for the maintenance treatment of patients with epithelial ovarian cancer (EOC) in complete remission (CR) following first-line chemotherapy
Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)
Feb 2012To determine which anthropometric parameters Lean body mass, total body mass or body surface area correlates best to docetaxel exposure (AUC) .
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Feb 2012This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice every 84 days
Feb 2012Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Feb 2012The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes.
Feb 2012To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.
Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia (PANTAP)
Feb 2012The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Feb 2012This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.
Randomised, Multicenter Phase III Clinical Study of Lipoplatin plus Gemcitabine Versus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer
Feb 2012To compare the activity and safety between the two arms of treatment.
A phase II trial of BKM120 (a PI3K inhibitor) in patients with triple negative metastatic breast cancer
Jan 2012To determine clinical activity of BKM120 in patients with metastatic triple negative breast cancer that have developed disease progression after standard chemotherapy in the adjuvant or metastatic setting.
A Phase II Randomized Open Label Study of MM-121 in combination with Paclitaxel versus Paclitaxel alone in patient with Platinum Resistant/Refractory Advanced Ovarian Cancers.
Jan 2012- To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents. - To correlate a pre-specified five biomarker panel reflective of ErbB3 signaling activity with the clinical outcome of patients (correlation between PFS and other clinical efficacy criteria with biomarker signature)
Taste, Smell and Chemotherapy (TASTY)
Jan 2012Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma
Jan 2012Overall Survival
Assessment of multidrug resistance in breast cancer with [11c]Tariquidar PET
Jan 2012To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC at baseline (diagnostic biopsy)
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (PAGIST)
Jan 2012Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
Jan 2012This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma.
a single arm open label international multi center study of the efficacy and safety of sunitinib malate (su011248, sutent®) in patients with progressive advanced metastatic well differentiated unresectable pancreatic neuroendocrine tumors.
Jan 2012To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well differentiated, unresectable, pancreatic neuroendocrine tumors per RECIST.
Optimal Tube Feeding Method in Head and Neck Cancer Patients
Jan 2012The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.
Pseudohyponatremia of Multiple Myeloma is True Hyponatremia
Jan 2012Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.
Melanoma Margins Excision Trial
Jan 2012Recent data analysis has shown that data are seriously lacking on the safety and efficacy of margins less than 2cm for melanomas >2mm in Breslow thickness, and arguably insufficient for melanomas >1mm in thickness, for loco-regional control of melanoma recurrence. No RCT currently addresses 1 vs 2cm margins for melanomas in the >1mm thickness group. A trial is needed to answer this question.
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
Jan 2012This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.
Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.
Jan 2012The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.
A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
Jan 2012To compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients.
Jan 2012To determine the estradiol suppression between the three treatment arms after three months.
A phaseI/II study of Sunitinib in young patients
Jan 2012To characterize the plasma PK profile of sunitinib and its active metabolite SU012662 in children and young adults with advanced (defined as unresectable without major morbidity, metastatic or recurrent) GIST.
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
Jan 2012To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
Jan 2012The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Jan 2012Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
Jan 2012The primary objective of this study is to determine the preliminary efficacy of administration of INNO-206 compared to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by progression-free survival, progression-free survival at 4 and 6 months, tumor response and overall survival.
Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
Jan 2012Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse. It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse.
Additive Homeopathy in Cancer Patients (HIC)
Jan 2012The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment. The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.
Study for prevention of peritoneal carcinomatosis in patients with stomach cancer
Jan 2012Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC
Study for prevention of peritoneal carcinomatosis in patients with stomach cancer
Jan 2012Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC
A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Jan 2012To assess the progression-free survival of oral veliparib in combination with temozolomide or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and metastatic breast cancer.
A Phase I/II Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC) whose Disease has Progressed after Docetaxel Chemotherapy
Jan 2012To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in patients with metastatic CRPC To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of PSA response rate
Phase II trial of palliative Epirubicin, Oxaliplatin & Capecitabine (EOX) Chemotherapy combined with omega-3 fish oil infusion (omegaven) in patients with oesophago-gastric carcinoma
Jan 2012To see whether adding intravenous ω-3 FA emulsion to standard palliative chemotherapy (EOX) improves quality of life and/or prognosis, in patients with incurable gastric or oesophageal carcinoma.
Masitinib in Gastro-intestinal Stromal Tumor (GIST) Resistant to Imatinib
Jan 2012The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors
Jan 20121-year survival rate of "good risk" patients who develop Rash under treatment with gemcitabine/erlotinib
Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Jan 2012Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Jan 2012This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration.
Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 7.6
Jan 2012Response rate (RR) estimate by the investigator
Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 8
Jan 2012The purpose of this study is to assess the response rate
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
Dec 2011The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.
Role of PET/CT with 18F-choline in biochemical relapse in prostate cancer patients treated with radical intent. Pet Col study.
Dec 2011To assess the sensitivity of Pet Ct
Perioperative FOLFOXIRI and bevacizumab compared with postoperative FOLFOX in patients with resectable liver metastases from colorectal cancer (PERIMAX).
Dec 2011The primary objective of this study is to evaluate the efficacy of 5-Fluorouracil (5-FU) and oxaliplatin (FOLFOX-Regimen) for 6 months postoperatively compared to 5-FU, oxaliplatin and irinotecan (FOLFOXIRI-Regimen) with bevacizumab for three months pre- and three months postoperatively for resectable liver metastases from colorectal cancer.
Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma
Dec 2011This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate Cancer ConWeCab
Dec 2011To determine if a weekly regime improves tolerability of cabazitaxel compared to the standard 3 week regimen
A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer
Dec 2011Evaluation of progression-free survival of subjects following treatment with MEDI-575 when used in combination with paclitaxel/carboplatin versus paclitaxel/carboplatin alone in subjects with previously untreated, advanced non-small cell lung cancer
Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)
Dec 2011This Phase II trial aims to explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.
Correlation Between RECIST-conventional Imaging Techniques, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer
Dec 2011The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with bevacizumab in combination with XELOX.
Biological, Pathological and Imagery Markers in the First-Line Treatment of Metastatic Clear-Cell Renal Cell Carcinoma
Dec 2011The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2011All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B
Dec 2011Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.
HD-R3i - A prospective, randomized, placebo-controlled, international, multicenter phase I/II trial of RAD001 (everolimus) in combination with DHAP as induction therapy in patients with relapsed or refractory Hodgkin Lymphoma
Dec 2011The main objectives of this study are to identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP) and to demonstrate the efficacy of Ever-DHAP as induction therapy
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery
Dec 2011Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion. Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
Dec 2011This study aims to compare two different follow up regimens with different test intensity in endometrial cancer treated patients.
Letrozole as a Treatment of Endometrial Cancer
Dec 2011The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues.
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Dec 2011The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.
Characterization of the Melanoma-Specific Immune Response
Dec 2011The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.
Neurotropic Melanoma of the Head and Neck
Dec 2011This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery
Intra-arterial Chemotherapy for Children With Retinoblastoma
Dec 2011Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
Quality of Life in Children Cured of Retinoblastoma
Dec 2011The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.
Cisplatin, Etoposide, and Two Different Schedules of Radiation Therapy in Treating Patients With Limited Stage Small Cell Lung Cancer
Dec 2011This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
Dec 2011Comparison of two combination chemotherapies in the treatment of patients with SLCL
Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma
Dec 2011A recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with Doxorubicin. This finding suggest that the possibility of potentiation of the cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The association of Sorafenib with Ifosfamide, the other established active agent against STS, could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity .
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
Dec 2011The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells; to test the safety of the combination of sunitinib and radiotherapy.
Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer
Dec 2011To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Dec 2011This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma.
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma
Dec 2011The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Dec 2011The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.
National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations
Dec 2011The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.
STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)
Dec 2011This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Dec 2011The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Laparoscopic Approach to Cervical Cancer
Dec 2011The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix
Dec 2011Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.
Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix
Dec 2011A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix. Studies have shown improvement in survivals with chemoradiation, but majority of the patients was in early stages. Since this treatment modality has not been tested adequately in advanced stages in our setting, the present study is being undertaken. The study arm of chemoradiation has the potential to improve the survivals by 10%, but is associated with additional 5% risk of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy treatment, you will receive weekly chemotherapy injections (Cisplatin) during external radiation therapy. The study arm is associated with additional 5% acute hematological and gastrointestinal toxicities, which are treatable with medications, blood transfusions, modifications in the ongoing treatment etc.
Tasigna in Glivec-resistant or Intolerant Patients in CML
Dec 2011The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.
Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia
Dec 2011The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Dec 2011The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
Preoperative Assessment of Colon Tumor
Dec 2011The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.
Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy
Dec 2011The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.
Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer
Dec 2011The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC.
Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer
Dec 2011The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients undergoing transthoracic, partial or total resection of the esophagus for cancer.
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial
Dec 2011The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
Dec 2011This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.
A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/Refractory Multiple Myeloma.
Dec 2011To compare Progression Free Survival between treatment arms in the overall population.
A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer
Dec 2011Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?
A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer
Dec 2011Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?
A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects
Dec 2011To compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 with bevacizumab in combination with mFOLFOX6 based on investigator radiological tumor assessment.
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study.
Dec 2011To evaluate the analgesic efficacy of pregabalin in pancreatic cancer induced abdominal pain
An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases
Dec 2011To assess the efficacy of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN without distant metastases by means of non-progression rate at 6 months
A Randomized, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer
Dec 2011(1) To evaluate the effect of MK-1775 in combination with paclitaxel + carboplatin compared with placebo in combination with paclitaxel + carboplatin on PFS per enhanced RECIST 1.1 in patients with platinum sensitive p53 mutant ovarian cancer. (2) To determine the safety and tolerability of MK-1775 in combination with paclitaxel + carboplatin in patients with platinum sensitive p53 mutant ovarian cancer.
A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers
Dec 2011Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using each of the two randomly allocated PET tracers ([18F]FLT and [18F]FDG) as a method for evaluating response to systemic therapy in primary triple negative breast cancer at an earlier timepoint than is possible with standard imaging using MRI scans
Diagnostic accuracy of MRI, diffusion-weighted MRI, FDG-PET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma
Dec 2011This study will evaluate three new imaging techniques that may be used to identify malignant nodes preoperatively: (1) Diffusion Weighted MRI, (2) FDG-PET/CT and (3) FEC-PET/CT. The principal objective is to compare the diagnostic performance of each test (detection and false-positive rates) with that of the standard method (size criteria) with histology as the reference standard.
A Phase II, Single Arm, Investigative Study of IMM-101 in Combination with Radiation Induced Tumour Necrosis in Patients with Previously Treated Colorectal Cancer
Dec 2011To investigate the efficacy of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy.
An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced or metastatic esophageal squamous cell cancer
Dec 2011To demonstrate superiority of 5-fluorouracil, cisplatin and panitumumab over 5-fluorouracil and cisplatin alone in terms of overall survival in esophageal cancer
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Nov 2011To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers
A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer
Nov 2011In women with locally advanced cervical cancer, does the addition of weekly chemotherapy prior to chemoradiation alone improve overall survival compared with chemoradiation alone?
A randomised phase 2 study of paclitaxel with or without GSK1120212 in advanced wt BRAF melanoma
Nov 2011Phase 1 - To establish the maximum tolerated dose of GSK1120212 in combination with paclitaxel in the treatment of patients with advanced melanoma. Phase 2 - To compare the efficacy of GSK1120212 in combination with paclitaxel, compared with paclitaxel alone in the treatment of patients with advanced or metastatic melanoma.
LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung
Nov 2011To compare the progression-free survival (PFS) and disease control rate (at 12 months) of afatinib with gefitinib among patients with adenocarcinoma of the lung harbouring activating EGFR mutations who have no prior systemic chemotherapy in advanced setting (stage IIIB or IV)
A phase III, randomized, active controlled, assessorblinded study of safety and efficacy of Pegylated Apofilgrastim versus US and EU licensed Neulasta® in subjects with stage IIa, IIb or IIIa breast cancer receiving TAC anticancer chemotherapy in adjuvant setting
Nov 2011To demonstrate an equivalent efficacy of Pegylated Apo‐Filgrastim as compared to each of the commercially available US and EU licensed Neulasta® in patients suffering from early breast cancer and receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in adjuvant setting.
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
Nov 2011To ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).
Randomised phase II window study of short-term preoperative treatment with the PI3K inhibitor GDC-0941 plus Anastrozole versus Anastrozole alone in patients with ER-positive primary breast cancer
Nov 2011In women with ER-positive breast cancer about to undergo surgery, does two week's pretreatment with a new drug (the PI3K inhibitor GDC-0941, given in combination with the estrogen-blocker anastrozole) increase the benefits of anastrozole in slowing down tumour cell growth, as measured by laboratory measurements on tumour cells?
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trial
Nov 2011To assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of PSA in patients treated with BT for low-intermediate risk localized prostate carcinoma
A phase I/II, randomized, open-label, multi-centre study of BIBF1120 + reirradiation (R-RT) versus reirradiation in the treatment of patients with first or second progression of glioblastoma
Nov 2011Phase I - Maximal tolerated dose of BIBF1120 in combination reirradiation - Safety and tolerability of BIBF1120 in conjunction with radiotherapy - Pharmacokinetic studies in plasma and cerebrospinal fluid Phase II Primary objective: - 6 months rate of progression-free survival (PFS6)
Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Head and Neck Cancer.
Nov 2011Determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in head and neck cancer tumors
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Nov 2011The objective of this study is to see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM)
Nov 2011To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR))
Phase II pilot, prospective, open label, multicenter Clinical Trial, to evaluate the safety and efficacy of PF299804, a pan-HER irreversible inhibitor, in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation
Nov 2011To assess progression-free survival (PFS) at six months (PFS6m) in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation.
A randomized, double-blind, parallel-group, multi-center Phase III study comparing the efficacy and safety of EP2006 and Neupogen® in breast cancer patients treated with myelosuppressive chemotherapy
Nov 2011To assess the efficacy of EP2006 compared to Neupogen® (US-licensed) with respect to the mean duration of severe neutropenia (DSN), defined as the number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.
Everolimus in Refractory Testicular Germ Cell Cancer
Oct 2011Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
FLT-PET Imaging of Brain Tumors in Children
Oct 2011Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children.
Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated with Docetaxel.
Oct 2011Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.
Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT
Oct 2011The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.
DOVIGIST: Phase II trial to evaluate the efficacy and safety of Dovitinib (TKI258) in patients with gastrointestinal stromal tumors refractory and/or intolerant to imatinib
Oct 2011To assess the antitumor activity of Dovitinib (TKI258) in terms of disease control rate (DCR): CR+PR+SD, at 12 weeks in adult patients with documented disease progression while on therapy with imatinib for unresectable and/or metastatic GIST, recurrent GIST on adjuvant imatinib or within the first 3 months after discontinuation of adjuvant imatinib or, unresectable and/or metastatic GIST intolerant to imatinib
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma (ISG/OS-2)
Oct 2011The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein
A phase I/IIa study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes simplex virus HSV1716 into the tumour-bearing pleural cavity (intrapleural) in patients with inoperable malignant pleural mesothelioma.
Oct 2011The principal research objective is to investigate whether HSV1716 is safe and well-tolerated when administered directly into the cavity that surrounds and protects the lungs (pleural cavity) of patients with a type of cancer that originates from the linings of the pleural cavity (malignant pleural mesothelioma). The study will assess this question in the context of three groups of patients. One group will receive a single dose of HSV1716, the second group will receive two doses and the third group will receive four doses.
A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Oct 2011This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma.
Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme
Oct 2011This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
Oct 2011The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study
Oct 2011Is a multimodal intervention for cancer cacheixa feasible? Specific indiviudal treatments such as exercise, nutritional advice, dietary supplements and anti-inflammatory medications have been shown to be beneficial in isolation in the treatment of cancer cachexia. It is hypothesized that combining all of these as a "multimodal intervention" may be beneficial. Before a definitive study is conducted to assess this, it is important that the feasibility of delivering such an intervention is assessed - which is the purpose of the proposed study. The feasibility will be assessed by: Enrolment rate, Compliance with study intervention, study procedures and data collection, Contamination-rate in the control group with respect to any of the interventions in the intervention group, and Provide an estimate of the sample size required in futures studies in cachexia.
AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
Sep 2011To determine the optimum doses of AZD2281 and carboplatin that can safely be used in patients with breast and ovarian cancer. To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
Sep 2011The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light.
Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.
Sep 2011Investigate whether the administration of HIPEC with Cisplatin (75 miligrams per square meter of body surface) after surgical cytoreduction in women with ovarian , tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
Sep 2011The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer surgery.
Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed after Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study
Sep 2011To assess the adherence rate to pemetrexed administered in a domiciliary setting.
An open-label, single-arm, multi-center phase II study to evaluate the efficacy and safety of AUY922 in combination with trastuzumab standard therapy as second-line treatment in patients with HER2-positive advanced gastric cancer
Sep 2011To assess the preliminary efficacy of AUY922 in combination with trastuzumab standard therapy, using Objective Response Rate (ORR), as per investigator, in advanced HER2+ gastric cancer patients progressing on 1st line trastuzumab containing treatment
FES-PET to Determine ER-expression in Epithelial Ovarian Cancer
Sep 2011In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.
Pazopanib in advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib . A non-comparative phase II multicenter study by the Scandinavian Sarcoma Group
Sep 2011Calculate the disease control rate (DCR)=complete remission (CR)+partial remission (PR) + stable disease (SD) at 12 weeks
Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue
Sep 2011Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets / Determinación de la proporción de pacientes vivos tras 12 meses del inicio del ensayo en enfermos con carcinoma de páncreas avanzado seleccionados de forma individualizada y agrupados en función de la expresión en tejido tumoral de Dianas Terapéuticas.
Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue
Sep 2011Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets.
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
Sep 2011Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.
A randomized, double-blind study of capecitabine plus tesetaxel versus capecitabine plus placebo as second-line therapy in subjects with gastric cancer
Sep 2011To evaluate the efficacy and safety of capecitabine plus tesetaxel (capecitabine-tesetaxel) versus capecitabine plus placebo (capecitabine-placebo) as second-line therapy in subjects with gastric cancer
First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma
Sep 2011Primary analysis will focus on the rate of poor risk patients as defined by the MSKCC criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib.
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens
Sep 2011Compare the overall survival (OS) of patients receiving E7080 + BSC with those receiving placebo + best supportive care (BSC)
A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/ capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Sep 2011To compare the duration of overall survival in patients who are randomized at enrollment to treatment with one of two trastuzumab dosing regimens (loading dose of 8mg/kg) followed by either 6mg/kg or 10mg/kg maintenance doses given every 3 weeks, plus cisplatin and capecitabine.
Prospective, explorative trial for the detection of circulating cell-free tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a tyrosine kinase inhibitor or progressive disease irrespective of current or planned treatment. An open-label, non-randomized, multicenter phase IIIb clinical trial.
Sep 2011Goal of the study is to investigate whether tumor-specific CKIT or PDGFRA DNA fragments can be detected and quantified in the plasma of patients with active GIST as defined as GIST lesions that can be measured by diagnostic imaging.
An open label study to determine the efficacy of ferric carboxymaltose in preoperative colorectal cancer related anaemia, and to develop biomarkers to predict response to this treatment strategy
Sep 2011The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?
United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
Sep 2011The UKALL 2011 trial will examine whether three changes to current standard therapy improves survival and reduces side effects in patients suffering from acute lymphoblastic leukaemia and lymphoblastic lymphoma. The following questions will be answered: 1) Does exposure to the steroid dexamethasone for a shorter period but at a similar total dosage than is currently used during the first month of treatment, result in fewer side effects whilst maintaining efficacy of treatment. 2) Does the use of methotrexate in high dose, reduce risk of relapse involving the central nervous system. 3) Is it possible to omit monthly pulses of vincristine and dexamethasone, currently given for up to 30 months, without increasing the risk of relapse, thereby reducing side effects and improving health related quality of life.
A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate Cancer
Aug 2011The primary objective of the study is to determine the safety and tolerability of orally-administered VT-464 in chemotherapy-naïve patients with castration-refractory prostate cancer (CRPC).
A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)
Aug 2011To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.
A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)
Aug 2011To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.
A Phase 1b/2 Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)
Aug 2011Phase 1b: To determine a safe/tolerable Phase 2 dose of LY2157299 for combination with gemcitabine in patients with solid malignancy, who failed previous approved therapies and/or are amenable to gemcitabine therapy (eg, pancreatic cancer, biliary tract, sarcoma). Phase 2: To compare overall survival (OS) in patients with Stage II-IV unresectable pancreatic cancer when treated with the combination of LY2157299 and gemcitabine with that of gemcitabine plus placebo.
STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial
Aug 2011To compare the time it takes for the patient's cancer to get worse (tumour gets bigger) when treated with olaparib, as opposed to those patients that receive placebo.
PARAGON: Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms
Aug 2011The principal objective of the study is clinical benefit rate determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment.
Study Determining the Safety and Tolerability of Combination Therapy With Pazopanib and GSK1120212 in Advanced Solid Tumors Enriched With Patients With Advanced Differentiated Thyroid Cancer
Aug 2011The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and advanced thyroid cancer and identify the maximum tolerated dose (MTD) of this combination for phase II study.
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy
Aug 2011To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
Aug 2011This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung Cancer
Aug 2011The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation. Topotecan is approved for second line therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents should yield greater antitumor activity.
Proof of mechanism pre-surgical window trial of metformin in non-diabetic women with endometrial carcinoma: a feasibility study
Aug 2011To determine whether metformin exerts any effect in endometrial cancer.
A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma
Aug 2011During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of CHR-3996 and tosedostat administered in combination in subjects with relapsed or refractory multiple myeloma. In the dose expansion phase the purpose of the study is to determine the safety profile of CHR-3996 and tosedostat administered in combination and to estimate the response rate.
Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer
Aug 2011To facilitate the access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale
A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC
Aug 2011To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea
An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.
Aug 2011To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.
Testosterone Replacement in Young Male cancer Survivors
Aug 2011The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone.
Veliparib (ABT888) Monotherapy for Patients with BRCA germline mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
Jul 2011Phase I: To determine: • Maximum-tolerated dose (MTD) • Dose-limiting toxicities (DLT) • Recommended phase II dose Phase II: To investigate the response rate in platinum-resistant and partially platinum sensitive ovarian cancer patients with known BRCA mutations treated with veliparib monotherapy.
A randomized double-blind phase 3 trial comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/doxil®/caelyx®) in combination versus PLD in participants with platinum-resistant ovarian cancer
Jul 2011Compare progression-free survival (PFS), based upon investigator assessment using RECIST v 1.1 in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD) (i.e., EC145 + PLD) with that of participants with platinum-resistant ovarian cancer who receive PLD and placebo.
Association Between Hepatitis C Infection and Renal Cell Carcinoma
Jul 2011The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).
Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)
Jul 2011To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by inspecting the bladder under white light first, followed by blue light.
ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients
Jul 2011The principal research question for the phase III trial is to determine whether patient survival rates are no worse (non-inferior) for patients that do not receive Radioactive Iodine (RAI) ablation compared to those that do.
LUX-Head & Neck 1 - A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy
Jul 2011To investigate the efficacy of afatinib versus methotrexate therapy in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy given for R/M HNSCC
A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I- Refractory Differentiated Thyroid Cancer
Jul 2011To compare the progression-free survival of subjects with 131I-refractory differentiated thyroid cancer with radiographic evidence of disease progression within the prior 12 months treated with E7080 versus placebo.
Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma
Jul 2011The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4, CD47, and beta 2 adrenergic receptors) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma.
Phase 1 Study of Combotox With Cytarabine in Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia (ALL)
Jul 2011This study will test different doses of combotox in your disease to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine. You might have been given cytarabine as part of your treatment for ALL before; even if you have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed"). Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on you and your disease (ALL) when combined with cytarabine.
Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia
Jul 2011The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.
A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
Jul 2011To evaluate the efficacy in term of progression-free survival after randomization (PFSrand) of a subcutaneous (SC) formulation of rituximab in patients who responded to Induction and initial 2 years maintenance therapy (Maintenance I), and were randomized to either prolonged rituximab maintenance until progression (Maintenance II) or observation.
LUX-Head & Neck 2. A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma
Jun 2011To investigate the efficacy and safety of afatinib compared to placebo as adjuvant therapy after chemo-radiotherapy in patients with loco-regionally advanced head and neck squamous cell carcinoma. Efficacy will be measured by comparing Disease Free Survival (DFS) between the two arms.
An open-label, multi-center, expanded access study of everolimus in patients with advanced neuroendocrine tumors
Jun 2011To evaluate additional safety of everolimus in patients with advanced neuroendocrine tumors of pancreatic origin.
A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON)
Jun 2011We propose a study to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. The study aims to determine the efficacy of carbogen gas breathing and nicotinamide tablets, given during a course of intensity-modulated radiotherapy to the prostate gland in previously untreated patients with prostate cancer.
Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia (HPV-cancer)
Jun 2011The aim of this study is to describe the pre-vaccination distribution of HPV genotypes in women with high grade cervical squamous intraepithelial lesion (HSIL) and cervical cancer in Croatia.
Efficacy, tolerability and safety of Temsirolimus in women with platinum-refractory ovarian carcinoma or advanced endometrial carcinoma
Jun 2011To assess the progression-free survival rate after 4 months (recurrent ovarian cancer) or 6 months (endometrial cancer)
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
Jun 2011The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.
A Phase III, open-label, multicentre, randomised trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care
Jun 2011To assess overall survival (OS) of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients when compared to the control group receiving best treatment and supportive care.
Characterization of focal liver lesions with Sonovue(R)-enhanced ultrasound imaging: a phase III, intrapatient comparative study versus unenhanced ultrasound imaging using histology or combined imaging/clinical data as truth standard.
Jun 2011To demonstrate the sensitivity and specificity of Sonovue-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant focal liver lesions (FLLs) using final diagnosis based on histology or combiend imaging (CE-CT and/or CE-MRI)/clinical data as truth standard.
A multi-center, randomized, open-label, mechanism of action trial on the biological effects of the therapeutic cancer vaccine Stimuvax® (L-BLP25) in rectal cancer subjects undergoing neoadjuvant chemoradiotherapy. Stimuvax® (L-BLP25) in rectal cancer in neoadjuvant chemoradiotherapy (SPRINT)
Jun 2011The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against carcinoembryonic antigen [CEA] and mucinous glycoprotein 1 [MUC1], tumor-infiltrating lymphocytes [TILs]) in subjects with rectal cancer undergoing neoadjuvant chemoradiotherapy. The immune response will be evaluated based on the local response in the tumor and the MUC1- and CEA-specific response tested in blood. CEA-specific immune response will indicate antigen spreading.
MR Image Guided Therapy in Prostate Cancer
Jun 2011To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.
A prospective randomised Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.
Jun 2011To compare progression-free survival (PFS) (by RECIST v1.1, clinical or symptomatic) of patients randomized to front-line paclitaxel/carboplatin with bevacizumab for 15 months or 30 months.
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Jun 2011This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma, and the secondary end-point is correlating these changing with treatment activity.
Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer (CRICERVA)
Jun 2011The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.
NK Cell Based Non-Myeloablative Transplantation in (AML) Acute Myeloid Leukemia
Jun 2011This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid leukemia (AML). Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
Ultrasound Elastography in Patients With Rectal Cancer
Jun 2011The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.
A randomized, double-blind, placebo-controlled multi-center study of BYM338 for treatment of cachexia in patients with stage IV non-small cell lung cancer or stage III/IV adenocarcinoma of the pancreas
Jun 2011To assess the preliminary efficacy of a single intravenous dose of BYM338 in increasing thigh muscle volume as assessed by Magnetic Resonance Imaging compared to placebo.
Trial of Radiation Therapy "Sandwiched" Between Chemotherapy to Treat Uterine Carcinosarcoma
Jun 2011The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
Jun 2011The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital.
Trial of Radiation Therapy "Sandwiched" Between Chemotherapy to Treat Uterine Carcinosarcoma (MMMT)
Jun 2011The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
Jun 2011The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years.
Sexual Behavior in Head and Neck Cancer Patients
Jun 2011The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.
An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of vemurafenib in metastatic melanoma patients with brain metastases
May 2011To evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of metastatic melanoma patients with previously untreated brain metastases
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy
May 2011To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
May 2011The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).
Panitumumab after Resection of Liver Metastases from Colorectal Cancer in KRAS Wild-type Patients -PARLIM-
May 2011The study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody.
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
May 2011This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer
May 2011The main objective of the trial is to compare overall survival (OS) of subjects with locallyadvanced pancreatic cancer (LAPC) who are randomized to receive dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo
Lenalidomide, Lenalidomide + Azacitidine, or Standard Treatment Therapies in Newly Diagnosed Acute Myeloid Leukemia
May 2011The aim of the study is to investigate the effect of a lenalidomide regimen or a sequential azacitidine plus lenalidomide regimen relative to the conventional care regimens in subjects 65 years or older with newly diagnosed Acute Myeloid Leukemia (AML).
PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
May 2011The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity.
NGR018: Randomized phase II study of NGR-hTNF plus pegylated liposomal doxorubicin (PLD) versus PLD in platinum-resistant ovarian cancer
May 2011To compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus PLD versus patients randomized to PLD
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
May 2011The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults
May 2011The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
A Phase IIb/III, Double-Blind, Placebo-Controlled, Randomized Study Investigating the Safety, Tolerability and Efficacy of Flupirtine as Adjunct to Opioids When Administered to Cancer Subjects Who Are Experiencing Pain With Neuropathic Features
May 2011The primary objective of this study is to explore the overall analgesic efficacy of flupirtine administered in combination with opioids for a period of 5 weeks.
An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine
May 2011To evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (sorafenib-naïve patients).
Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours
May 2011This study aims to evaluate the tumour response
Patient Activation, Consultation and Exercise - Acute Leukemia (PACE-AL)
May 2011The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm
May 2011Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms of overall survival and disease-free survival. This has prompted some authors to suggest that PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous experience, some tumors (with deep locations, which were included as "central HCC") may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the investigators conducted a study that included a consecutive series of patients with single resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.
A multicenter, phase III, open-label, randomized study in previously untreated patients with advanced indolent non-hodgkin's lymphoma evaluating the benefit of GA101 (RO5072759) plus chemotherapy compared with rituximab plus chemotherapy followed by GA101 or rituximab maintenance therapy in responders
May 2011Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY)
May 2011A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
Study of Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Minimal Residual Disease in Acute Myeloid Leukemia
May 2011Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.
Rasagiline treatment for Sleep disorders in Parkinson´s disease
Apr 2011Reduction of sleep disturbances
Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer
Apr 2011This research study is studying biomarkers in blood and tissue samples from patients with uterine cancer.
Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery
Apr 2011To increase the disease-free survival after 3 years follow-up
A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)
Apr 2011The primary objective of this study is to evaluate the tumor response of stable disease (SD) or better at 12 weeks in two separate cohorts representing molecularly distinct subsets of previously treated patients with GIST when treated with IMC-3G3: Cohort 1 includes patients with GIST harboring PDGFRα mutations (D842V and any others), while Cohort 2 includes patients with GIST not harboring PDGFRα mutations.
Prospective, randomized, controlled, open-label study evaluating quality of life in patients with advanced malignant tumors with and without “add-on” homeopathy
Apr 2011Reveal and describe the difference in Qol and SWB, in patient groups receiving standard treatment and “add on” homeopathic treatment. The null hypothesis is that “add-on” homeopathic treatment does not create a benefit for cancer patients with regard to QoL and SWB.
An open-label, multicenter Phase Ib/2 study of E7080 alone, and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.
Apr 2011Phase Ib: To determine the dose limiting toxicities and maximally tolerated dose and establish the recommended phase 2 (RP2) dose for E7080 incombination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma (RCC). Phase 2: To compare the progression free survival of 1) E7080 in combination with everolimus at the RP2 dose once daily (Arm A) and 2) single agent E7080 24 mg once daily (Arm B) to single agent everolimus 10 mg once daily (Arm C) in subjects with unresectable advanced or metastatic RCC and disease progression following one prior VEGF targeted treatment.
A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with intravenous BHQ880, a fully human, anti-Dickkopf1 (DKK1) neutralizing antibody in previously untreated patients with high-risk, smoldering multiple myeloma
Apr 2011Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM
Randomised controlled open-label trial of TPF induction chemotherapy in the surgical management of locally advanced head and neck cancer
Apr 2011The primary aim is to determine whether enough patients agree to be randomised in this feasibility study so that the full phase III would be able to recruit the target sample size within 4 more years. This will be determined by setting up at least 4 centres, each of which should recruit an average of 1 patient per month during a 12 month period.
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Apr 2011This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors with or without brain metastases.
Apr 2011To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) in patients with solid tumors with our without brain metastases in order to determine the Maximum Tolerated Dose (MTD).
Safety of Vorinostat in combination with Bortezomib, Doxorubicin and Dexamethasone (VBDD) in patients with refractory or relapsed multiple myeloma
Apr 2011Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).
Prospective randomised controlled trial of video assisted thorascopic (VATS) cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven malignant mesothelioma
Apr 2011The principal aim of this study is to compare the effectiveness of video-assisted thoracoscopic (VAT) cytoreductive pleurectomy against talc pleurodesis for patients with pleural effusion secondary to mesothelioma We have chosen pleurodesis with talc (either via an intercostal chest drain or during thoracoscopy) as the principal control group because these are widely available and commonly used treatments for management of malignant pleural effusion. The Primary objective is to compare the effectiveness of talc pleurodesis against video-assisted thoracoscopic cytoreductive surgery in terms of survival at one year.
Genomic Testing for Primary Breast Cancer
Apr 2011The goal of this research study is to find out if researchers can use genetic testing on tumor samples to predict if tumors will respond to breast cancer treatments. The tumor sample will be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope that the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
GDC-0449 in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Who Received an Autologous Stem Cell
Apr 2011This phase I trial is studying how well GDC-0449 works in treating patients with high-risk first remission or relapsed multiple myeloma who received an autologous stem cell transplant.
Phase I/IIa study of immunization with a p16INK4a peptide combined with MONTANIDE ISA-51 VG in patients with advanced HPV-associated cancers
Apr 2011Phase I Part: Safety of the vaccine and Phase IIa Part: Immune response against the p16_37-63 peptide
Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors
Mar 2011This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.
SAPROCAN: Saracatinib (AZD0530) and docetaxel in metastatic, castrate-refractory prostate cancer: a phase I/randomised phase II study by the UK NCRI Prostate Clinical Studies Group
Mar 2011For the first part of the study (phase I), the primary objective is to find a safe and tolerable dose for saracatinib (AZD0530) given in combination with standard chemotherapy treatment (docetaxel and prednisolone) for patients with metastic castrate-refractory prostate cancer. For the second part of the study (phase II), the primary objective is to investigate whether we can improve the benefits of chemotherapy cancer treatment for patients with metastic castrate-refractory prostate cancer by adding a new drug, saracatinib (AZD0530).
Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma (OCUM)
Mar 2011The objective of the study is to provide proof that a MRI based preoperative radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to high risk patients without increase of locoregional recurrence rate and decrease of overall survival provided there is a high quality of mesorectal excision.
A randomized, open-label phase II multicenter study evaluating the efficacy of oral Everolimus alone or in combination with Pasireotide LAR i.m. in advanced progressive pancreatic neuroendocrine tumors (PNET)
Mar 2011To estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a possible subsequent phase III study once 80 PFS events have been observed.
Treatment Protocol for young adults (18-45 years of age) with Acute Lymphoblastic Leukemia
Mar 2011To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect. To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed. To test if replacing six doses of conventional triple i.t. therapy with DepoCyte® during maintenance therapy for HR-ALL will yield an equal or reduced rate of serious toxicity (SAEs and SUSARs) with a similar or decreased CNS- and overall relapse rate
A phase II trial to assess the safety, immunological activity of Trovax plus Pemetrexed/ Cisplatin in patients with malignant pleural mesothelioma.
Mar 2011To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM for Prevention of Venous Thromboembolism in Gynecologic Oncology Patients
Mar 2011Prophylactic treatment will start from surgery until the patients are discharged from the hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The first visit will be 2 weeks from discharge & the second visit will be 3 months after surgery. In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically & radiologically if needed ( spiral CT, V/Q scan & lower limp Doppler ). Any side effect or adverse reaction will be reported & it will be evaluated if it is related to the drug used or not.
Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Mar 2011SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Mar 2011SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
A Phase II Study of PM01183 as Second-line Treatment in Patients with Metastatic Pancreatic Cancer
Mar 2011To evaluate the antitumor activity of PM01183 in terms of overall survival rate at 6 months (OS6) in patients with metastatic pancreatic cancer.
Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)
Mar 2011The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation programme for patients with invasive bladder cancer referred to surgery.
Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer
Mar 2011To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME).
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non–Small-Cell Lung Cancer (NSCLC)
Mar 2011The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. (PCM301)
Mar 2011To assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Mar 2011This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Mar 2011This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
A Randomized, International, Open-Label, Multi-Centre, Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with Vandetanib
Feb 2011To demonstrate a decrease in the percentage of time patients with locally advanced or metastatic medullary thyroid cancer experience AEs of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of a patient outreach programme
Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes
Feb 2011this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy
A phase 2, open-label, single-arm, efficacy and safety study of MDV3100 in patients with hormone-naïve prostate cancer
Feb 2011To evaluate the effect of MDV3100 on prostate-specific antigen (PSA)
Chemo- and Radiotherapy in Epithelial Vulvar Cancer (CARE)
Feb 2011This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy.
Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT): A phase 1/2 study of lenalidomide (Revlimid) in combination with cyclophosphamide (endoxan) and prednisone (REP) in relapsed/refractory multiple myeloma
Feb 2011Phase 1 Primary objective - To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. Phase 2 pimary objective - To investigate the efficacy of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone at the RDL, as determined by the (s)CR+VGPR+PR rate.
VIP: A prospective, phase II, double blinded, multicentre, randomised clinical trial comparing combination gemcitabine and vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic pancreatic carcinoma.
Feb 2011To assess whether overall survival time using gemcitabine plus vandetanib is longer than that using gemcitabine alone as the first treatment for advanced or metastatic pancreatic cancer.
A New Patient Reported Outcome Instrument to Assess Symptom Experience in Women With Vulvar Neoplasms (WOMAN-PRO)
Feb 2011The study aims to develop and validate a postoperative instrument to assess symptom experiences in women with vulvar neoplasms.
Breast Cancer Prevention Education
Feb 2011We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are: To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research. Secondly to evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.
Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
Feb 2011To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer.
Feb 2011The purpose of this trial is to evaluate the toxicity for intermediate and high risk NMIBC, after complete transurethral resection of all papillary tumours, of an intravesical sequential treatment combining MMC (mitomycine c) 40mg and BCG (Bacillus Calmette-Guérin) 1/10th , 1/6th and 1/4 dose. MMC will act as an apoptosis inductor and BCG as a recruiter of immune effectors, among which DCs. We then hope to obtain, in addition to the classical response to MMC, an immune response with a presentation of TAA in association with MHC class I able to induce a specific CTL-mediated response directed against the tumour. The study is designed to evaluate the safety and severity of acute side effects of the treatment.
A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
Feb 2011No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: Local and systemic toxicities, Number, type and degree of toxicities as measured by the NCI CTCAE v4.0, and QoL (EORTC QLQ-C30 supplemented with EORTC QLQ-PAN26).
An Open-Label, Multi-Center Phase I/IIa Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Oral Tasidotin HCL in Patients with Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphomas
Feb 2011To determine the safety and tolerability of Tasidotin HCl administered orally for 14 consecutive days every 28 days cycle by identifying the MTD when administered in patients with relapsed/refractory aggressive non-Hodgkin’s lymphomas
GCPGC in Chemotherapy-induced Neutropenia
Feb 2011This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC and stage II is multi-center, parallel-group, open label,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to daily filgrastim
An open-label, randomized, phase 3 study of inotuzumab ozogamicin administered in combination with rituximab compared to defined investigator’s choice therapy in subjects with relapsed or refractory CD22-positive aggressive non-hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy
Feb 2011To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.
Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
Feb 2011The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib
Feb 2011The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS), per blinded central radiology review, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).
NGR019: Randomized double-blind phase II study of NGR-hTNF versus placebo as maintenance treatment in advanced malignant pleural mesothelioma (MPM)
Feb 2011To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo
A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
Feb 2011To evaluate tumor regression as determined by ORR in patients receiving CAL-101 for treatment of iNHL refractory to rituximab and alkylating agents
Explorative trial to investigate catumaxomab (anti-EpCAM x anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric adenocarcinomas prior to gastrectomy
Feb 2011The main objective of this trial is to investigate the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy. The primary endpoint is the rate of macroscopic complete remissions of peritoneal carcinomatosis at the second diagnostic laparoscopy or laparotomy.
Explorative trial to investigate catumaxomab (anti-EpCAM x anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric adenocarcinomas prior to gastrectomy
Feb 2011The main objective of this trial is to investigate the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy. The primary endpoint is the rate of macroscopic complete remissions of peritoneal carcinomatosis at the second diagnostic laparoscopy or laparotomy.
Colorectal Cancer Detection by Means of Optical Fluoroscopy
Jan 2011The aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA levels also occur in patients with benign disease, as well as in patients with other carcinomas. Nevertheless, surveillance programs are often based on the CEA test and combination with other markers is at present a matter of research. Alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. Few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For this purpose, the blood of patients was collected and the fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of 405 nm was selected for the study. The fluorescence emission spectra were recorded in the range of 430-700 nm.
Investigation of pathways regulating cell survival and early antiangiogenic response to single agent Rapamycin in Renal Cancer
Jan 2011Drugs that inhibit the mTOR enzyme have clinical activity in renal cancer, causing significant delay in disease progression, although with a low incidence of objective tumour regressions. This trial aims to identify early indicators of disease response or resistance.
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)
Jan 2011The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
A phase II trial of the addition of ipilumimab to carboplatin and etoposide chemotherapy for the first line treatment of extensive small cell lung cancer
Jan 2011The trial aims to answer whether the addition of Ipilumimab to carboplatin and etoposide chemotherapy for patients with extensive stage small cell lung cancer is able to improve outcome for these patients as assessed by the proportion of patients alive and without progression at 1 year.
A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds)
Jan 2011To demonstrate that administration of the 9-valent HPV L1 VLP vaccine induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 16 and anti-HPV 18 compared to GARDASIL® in preadolescent and adolescent girls 9 to 15 years of age.
A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma
Jan 2011The primary objective of the present phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib
Perioperative chemotherapy with FOLFOX plus Cetuximab versus adjuvant FOLFOX plus Cetuximab for patients with resectable liver metastases of colorectal carcinoma
Jan 2011The first primary objective of the study is to compare the postoperative complication rate according to Clavien score (> grade 1) of a perioperative chemotherapy with a postoperative regimen.
Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Jan 2011The primary objective of this study is to compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.
A phase II study to investigate the efficacy of cyclophosphamide as sole graft-versus-host-prophylaxis after allogeneic stem cell transplantation (OCTET-CY)
Jan 2011To assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer
Dec 2010To determine if treatment with AMG 706 in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).
ICON8: An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.
Dec 2010Over the three stages of the trial the principal research objectives are: 1. In stage 1, to determine the feasibility and safety of the two dose-fractionated carboplatin-paclitaxel regimens in the first-line treatment of ovarian cancer. This will be assessed in approximately the first 150 women entering the trial and additionally in approximately the first 150 women who enter the trial with a plan to undergo delayed primary surgery during chemotherapy. 2. In stage 2, to assess the activity of the two dose-fractionated regimens by recording the proportion of women in each arm who are alive 9 months and free from disease progression (9-month PFS) after randomisation in the trial. This will be assessed in approximately the first 186 women to enter the trial. 3. In stage 3, to compare the efficacy of the dose-fractionated regimens in treating ovarian cancer with that of standard 3-weekly carboplatin-paclitaxel chemotherapy. This will be assessed in terms of whether they res
Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide in Second Line Multiple Myeloma (MM)
Dec 2010To assess efficacy (TTP) of maintenance treatment with lenalidomide alone compared to a regimen with lenalidomide and low dose dexamethasone
A study of erlotinib (Tarceva®) treatment in patients with locally advanced or metastatic Non-Small Cell Lung Cancer who present activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor
Dec 2010Efficacy of erlotinib (TarcevaTM; 150 mg) on progression-free survival (PFS) in patients with non-small-cell lung cancer (NSCLC) in locally advanced or metastatic stages (stage IIIB and stage IV) who have not received previous chemotherapy for their disease and who present activating mutations in the tyrosine kinase (TK) domain of the epidermal growth factor receptor (EGFR).
A randomized, double-blind, multi-centre, placebo controlled phase II clinical study to evaluate the efficacy, tolerance and safety of an aqueous gel containing 2% (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3)
Dec 2010To evaluate the efficacy and the safety of an aqueous gel containing 2 % (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3).
A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer (CRITICS-study: ChemoRadiotherapy after Induction chemoTherapy In Cancer of the Stomach)
Dec 2010To assess whether postoperative chemoradiotherapy prolongs overall survival compared to postoperative chemotherapy in patients that have had adequate stomach surgery following preoperative chemotherapy
A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer
Dec 2010Phase I: Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY 86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part of this study
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
Dec 2010This phase II clinical trial is studying how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy.
Dose determination of Taxotere®, Eloxatin® and Xeloda® (TEX) in combination with Herpectin® as first line treatment to patients with HER2-positive non-resectable esophagus, cardia or gastric cancer
Dec 2010To determine maximum tolerable dose (MTD) for the combination regime TEX (docetaxel, oxaliplatin and capecitabine) + trastuzumab and to evaluate the toxicity
Neoadjuvant radiotherapy combined with capecitabine and sorafenib in patients with advanced, K-ras mutated rectal cancer. A randomized multicenter phase I/II trial.
Dec 2010Part I: to determine the recommended dose of the neoadjuvant regimen of capecitabine, sorafenib and external beam radiotherapy in patients with advanced K-ras mutated rectal cancer. Part IIa: to assess the efficacy and safety of the neoadjuvant regimen of capecitabine, sorafenib and external beam radiotherapy in patients with advanced K-ras mutated rectal cancer.
A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Dec 2010To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS).
Patient Reported Outcomes in Chronic Myeloid Leukemia
Dec 2010The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.
Electrochemotherapy as a palliative treatment for brain metastases
Nov 2010Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.
A study of lapatinib in combination with oxaliplatin and capecitabine in early HER-2 overexpressing oesophageal and gastric cancers
Nov 2010Is it possible to predict from the pretreatment tumour biopsies whether or not lapatinib will be effective at turning off HER2 signalling?
A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies.
Nov 2010Phase 1: The primary objective of the phase 1 portion of this study is to assess the safety and tolerability of MLN8237, formulated as an enteric-coated tablet (ECT), on a 7-day dosing schedule for determining the recommended dose and schedule of MLN8237 to be used in phase 2. Phase 2: The primary objective of the phase 2 portion of this study is to estimate the antitumor activity of MLN8237 as measured by overall response rate (ORR) in patients with advanced, unresectable nonhematological malignancies (NSCLC, SCLC, adenocarcinoma of the breast, HNSCC, or adenocarcinoma of the esophagus/gastroesophageal junction or stomach).
Fulvestrant with or without AZD6244, a mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor, in advanced stage breast cancer progressing after aromatase inhibitor: a randomized placebo-controlled double-blind phase II trial.
Nov 2010The primary objective of the trial is to assess the efficacy of the combination AZD6244-fulvestrant in patients with endocrine sensitive breast cancer progressing after aromatase inhibitors.
Optimizing tamoxifen therapy through the induction of CYP3A4, CYP2C and CYP2D6 mediated metabolism
Nov 2010To determine the influence of cytochrome P450 enzyme induction (including CYP3A4, CYP2C and CYP2D6) by rifampicin on the metabolism and plasma pharmacokinetics of tamoxifen and its metabolites in breast cancer patients.
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission Induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
Nov 2010To determine the prophylactic efficacy of AmBisome compared to placebo in preventing IFIs in subjects with ALL undergoing remission-induction chemotherapy.
Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer (RADIT)
Nov 2010The purpose of this study is to determine whether the drug everolimus is effective in the treatment of patients with relapsed cancer of the testis.
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Ovarian Cancer and Peritoneal Metastasis
Nov 2010The aim of the study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method, in patients with confirmed ovarian cancer in the presence of peritoneal metastases. This is to assess which of the two treatments (primary debulking surgery followed chemotherapy versus platinum-based neoadjuvant chemotherapy followed by interval debulking surgery, followed in turn by chemotherapy) is the best option for a particular type of patient.
Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer (HBC)
Nov 2010The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)
Nov 2010The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
Cytokine Changes After Colorectal Cancer Resection
Nov 2010Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.
Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer.
Nov 2010To test whether adjuvant tratment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation.
Chemo-Immunotherapy, gemcitabine with pegylated interferon alpha-2b (Peg-Intron) with and without p53 synthetic long peptide (p53 SLP) vaccine, for patients with platinum resistant ovarian cancer. CHIP trial
Nov 2010Determine the feasibility to combine gemcitabine and Peg-intron with and without p53-SLP vaccination
Multicenter, open-label phase ii study to evaluate the efficacy of a 2-cycle immunotherapy with the tri functional bispecific antibody catumaxomab (anti epcam x anti-CD3) in addition to systemic chemotherapy in patients with peritoneal carcinomatosis from gastric or colorectal adenocarcinoma
Nov 2010To decrease of the incidence of clinically significant malignant ascites (defined by one paracentesis of > 1500 ml or a cumulative amount of 1500 ml by multiple paracentesis within 10 days) from 40% (estimated value from the literature) to 15% within 9 months after first catumaxomab therapy.
Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel (NSCLC)
Nov 2010The purpose of this study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel.
Phase III Randomized Study of Adding Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide to Standard Chemotherapy in Patients With Non-Metastatic Extracranial Ewing Sarcoma
Oct 2010The primary objective of this trial is to test the effect of the combination of vincristine, cyclophosphamide, and topotecan (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free survival (EFS) and overall survival of children and young adults with Ewing sarcoma.
AIO KRK 0109 - An open-label 2:1 randomized phase II study of panitumumab plus FOLFOXIRI or FOLFOXIRI alone as first-line treatment of patients with non-resectable metastatic colorectal cancer and k-ras wild type (VOLFI)
Oct 2010To assess efficacy (overall response rate, ORR) of adding panitumumab to FOLFOXIRI in selected. I) patients with definitively unresectable metastatic disease, with a focus on symptomatic metastatic disease and/or large tumor load, or II) patients with chance of secondary resection with curative intent according to recent S3 guidelines of the German Cancer Society. The ORR will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.
A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI 906 plus Erlotinib (Tarceva®), or Erlotinib plus Placebo in Patients with Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC
Oct 2010The primary objective of this study is to determine the progression free survival (PFS) of maintenance OSI-906 plus erlotinib (Arm A), or erlotinib and placebo (Arm B) in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC.
MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer
Oct 2010MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation and renewal both under physiologically normal as well as in malignant conditions. Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies. In this proposal, specimens from patients treated in the clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be applied to develop specific therapies.
NGR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator’s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM)
Oct 2010To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC (Best Investigator Choice) versus patients randomized to placebo plus BIC
An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting
Oct 2010To investigate the efficacy and safety of BIBW 2992 (afatinib) alone and in combination with weekly treatment with paclitaxel or vinorelbine (in patients who progress on BIBW 2992 (afatinib) monotherapy only) as a new treatment algorithm in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant and/or adjuvant setting. The primary endpoint is Objective Response (OR) assessed by RECIST 1.1
Phase III Randomized Study of Standard Versus Extended Pelvic Lymphadenectomy During Radical Cystectomy in Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder
Oct 2010To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy.
Phase 2 Study of CS-7017 and Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Oct 2010To estimate the difference in efficacy, as measured by progression-free survival (PFS), between erlotinib in combination with CS-7017 and erlotinib alone.
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Oct 2010The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Oct 2010The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session).
A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET Imaging
Oct 2010To correlate the magnitude of [18F]AH111585 uptake and retention with quantitative measurement of the levels of avb3 integrin expression in tumours.
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
Oct 2010To determine if orteronel plus prednisone improves overall survival (OS)
Multicentre, single-arm, open label clinical trial intended to provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen and to document safety of cabazitaxel in these patients
Oct 2010To allow patients similar to those evaluated in the TROPIC trial, and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in patients who have progressed during or after docetaxel, and to document the overall safety of cabazitaxel in these patients.
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
Oct 2010It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.
A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy
Oct 2010To evaluate disease-free survival (DFS) with pazopanib (800 mg/day for 1-year) as compared to placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.
A Randomized Phase II Study of Afinitor (RAD001) vs. Sutent (Sunitinib) in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (ASPEN)
Oct 2010The primary endpoint will be a comparison of progression-free survival (PFS) between the treatment arms following therapy initiation. Disease progression is defined by documentation of progressive disease, a new primary malignancy, or death (whichever occurs first), censored at the last tumor evaluation date.
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma
Oct 2010The primary objective of this study is to determine the optimum dose of bendamustine when combined with thalidomide and dexamethasone (BTD) in the treatment of relapsed/refractory multiple myeloma, based on response rates, tolerability, and progression-free survival (PFS).
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
Oct 2010The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.
Determining the Maximum Tolerated Dose of Low Dose Interferon-alfa in Conjunction With Nilotinib in Imatinib Resistant and/or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) (NICOLI)
Oct 2010This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in imatinib resistant and/or intolerant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
A phase II study of pazopanib in patients with metastatic or unresectable renal cell carcinoma (RCC) who have failed prior sunitinib therapy
Oct 2010The primary objective of this trial is to assess Progression free survival at 4 months. Progression Free Survival is defined as the length of time between the date of starting treatment and the earliest date of disease progression or death due to any cause.
Etude de phase II randomisée multicentrique évaluant l'efficacité d’estramustine phosphate (Estracyt ®) chez des patientes présentant un cancer du sein métastatique HER2- / RH+ ayant déjà reçu un traitement par inhibiteur d’aromatase
Sep 2010To determine the percentage of progression free survival after a 6-month monotherapy of Estramustine in patients with HER2-/RH+ breast cancer progressing after having already undergone either a first line adjuvant treatment by aromatase inhibitors (AI)
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity in Patients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study)
Sep 2010Effect on progression free survival defined as the time measured from the day of registration to first progression or death.
A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
Sep 2010The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM).
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
Sep 2010The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion. The study population consists of all NSCLC patients who undergo "curative" lung cancer resection and whose tumors harbor hypermethylation in any of the protocol-specific genes (samples will be banked for additional molecular testing including other 21 loci which have shown to be important in lung carcinogenesis.
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
Sep 2010Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.
PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
Sep 2010The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.
A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Sep 2010To determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by progression-free survival (PFS), defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications or death from any cause in subjects with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Sep 2010The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole.
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Sep 2010This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer
Sep 2010To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab
Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT (Mupet)
Sep 2010The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC)
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Sep 2010This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice
Efficacy of Dexamethasone Switch in Prednisolone Resistant Adult ALL and Prolonged L-asparaginase in Non-interrupted Schedule
Aug 2010Evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more. Feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. Tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) Feasibility and efficacy of autologous HSCT for T-cell ALL.
ARISTOTLE - A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer.
Aug 2010This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer.
Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease
Aug 2010To determine the pharmacokinetics of anidulafungin given once in every 2 days (q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Aug 2010To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma. To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer (sncRNA)
Aug 2010The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.
Randomized Phase III trial on postoperative chemoradiation in combination with anti EGFR-antibody versus postoperative chemoradiation in head and neck squamous cell carcinomas (HNSCC) with high risk of locoregional recurrence
Aug 2010The proposed study tests the hypothesis that the addition of concurrently administered panitumumab to standard adjuvant chemoradiation significantly prolongs disease free survival in macroscopically completely resected advanced head and neck cancer at high risk of recurrence.
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma
Aug 2010To evaluate the effect of Lenalidomide given after reduced intensity conditioned stem cell transplant on progression-free survival at 2 years in myeloma
A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to Active Surveillance
Aug 2010To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and to determine the difference in risk of treatment failure associated with observed histological progression of disease in men with low risk prostate cancer who undergo TOOKAD® Soluble VTP compared to men on active surveillance (co-primary objective B).
Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma
Aug 2010The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib are effective treatments in patients with previously treated multiple myeloma.
Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
Aug 2010The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer. Revised Protocol Number 01 incorporating Administrative Letters 01 and 02 and Amendment 05 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 3.0 dated 11-Jan-10) + Immune Monitoring Amendment 04 (version 1.0 dated 18-Mar-11)-Site Specific
Aug 2010To compare overall survival of subjects with chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC) who have been randomized to ipilimumab vs placebo.
Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)
Aug 2010Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in subjects with unresectable and/or metastatic hepatocellular carcinoma.
Comparison Study of Narrow Band Imaging Versus White Lite Resection in Patients With Bladder Tumors/Cancer
Aug 2010The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.
Effectiveness of first line treatment with lapatinib and ECF/X in histologically proven adenocarcinoma of the stomach or the esophagogastric junction (metastatic or not amenable to curative surgery) according to HER2 and EGFR status: a randomized phase II trial
Aug 2010To test the activity of lapatinib in patients HER2 positive by FISH and by IHC 2+ and 3+.
SONATINA: A Phase II Multi-Centre Randomised Controlled Study of Nelfinavir Addition to Radiotherapy Treatment in Neo-Adjuvant Therapy for Rectal Cancer
Aug 2010To investigate the activity of the drug, Nelfinavir, when it is used to sensitise rectal cancer to radiotherapy treatment to try to make the radiotherapy more effective.
Symptom Inventory for Gastrointestinal Stromal Tumors
Aug 2010The goal of this research study is to better understand the symptoms experienced by patients with GIST. There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year. You are being asked to take part in Part 3 of the study.
A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia.
Aug 2010Assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL) primary objective:-To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
Study to Assess Safety and Tolerability of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Aug 2010The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.
An Open-Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed and/or Refractory Multiple Myeloma
Aug 2010•To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); •To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
Jul 2010The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.
Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT (PADIMAC)
Jul 2010What is the 2-year progression-free survival (PFS) for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment until clinical indication of relapse? This question is addressed separately for patients who are minimal residual disease positive (MRD+), and those who are MRD negative (MRD-), at end of induction chemotherapy.
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients
Jul 2010The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with chronic myeloid leukemia (CML). The safety of this drug will also be studied.
A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER + Breast Cancer Patients with EGFR Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic). (GLOW)
Jul 2010The main objectives of this trial are to assess the safety and tolerability and to determine a dose of AZD4547 in combination with a standard dose of exemestane. Also to assess the relative efficacy of AZD4547 in combination with exemestane compared with exemestane alone by comparison of the change in tumour size at 12 weeks.
Intérêt d'un traitement par cyclines dans la prévention de la toxicité cutanée du Cétuximab lors de son association à un FOLFIRI intensifié chez des patients avec un cancer colorectal en première ou deuxième ligne métastatique. Etude ouverte, multicentrique, randomisée, de phase III : SKINUX
Jul 2010Diminution de 30% de l'incidence de la toxicité cutanée à type d'éruption acnéiforme de grade supérieur ou égal à 2 lors d'un traitement préventif par cyclines pendant 6 semaines.
An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma
Jul 2010•To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) •To assess the safety and tolerability of brentuximab vedotin •In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL).
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer (DESKTOP III)
Jul 2010The goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.
A Phase II Trial of ProLindac™ and Paclitaxel Combination as Second Line-Treatment in Platinum Pretreated Patients with Advanced Ovarian Cancer
Jul 2010To evaluate the efficacy of ProLindac combined with paclitaxel in patients with advanced epithelial ovarian cancer, previously treated with cisplatin or carboplatin, who are potentially platinum-sensitive (platinum-free, progression-free interval 12 months)
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Jul 2010To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.
A randomized, open-label, multi-center phase II study to compare AUY922 with docetaxel or irinotecan in adult patients with advanced gastric cancer, who have progressed after one line of chemotherapy
Jul 2010The primary objective is to assess the treatment effect on progression-free survival (PFS) in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecan.
Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors
Jun 2010This phase I trial is studying the side effects and best dose of giving temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or metastatic solid tumors.
A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia
Jun 2010To evaluate the efficacy of blinatumomab to induce complete MRD response
The effect of eicosapentaenoic acid (EPA) on biomarkers of growth and vascularity in human colorectal cancer liver metastases
Jun 2010The study aims to show the first evidence of anti-cancer properties of EPA in human colorectal cancer liver metastases (CRCLM). In particular we want to see if treatment with EPA daily is associated with a lower ‘proliferation index’ (the amount of tumour cell growth) in CRCLM compared with placebo.
Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
Jun 2010The goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life
Phase II study of cetuximab combined with cisplatin or carboplatin/pemetrexed as first line treatment in patients with malignant pleural mesothelioma.
Jun 2010To investigate the activity and safety of the combination of cetuximab and platinum/pemetrexed as first line treatment in EGFR IHC positive mesothelioma patients.
Sentinel Concept in Early Stage Cervical Cancer
Jun 2010Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.
Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
Jun 2010The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE)
Jun 2010To evaluate 1. Overall survival (OS) at 2 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive. 2. Disease-free survival (DFS) at 2 years. Events for DFS in both arms are death and first relapse (either AML or MDS recurrence). 3. Changes in quality of life from diagnosis in both arms.
An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximab-refractory, indolent Non-Hodgkin’s Lymphoma
Jun 2010To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy
Use of Metformin to reduce serum level of Testosterone and improve the metabolic picture in women treated for breast cancer.
Jun 2010Relatively high level of Testosterone, due to insulin resistance, are asociated with higher risk of breast cancer (BC) and even of recurrences of BC. The main objective is to define the smallest dose of Metformin able to reduce augmented serum level of T and to modify other metabolic parameters in menopausal women on treatment for BC (randomised comparison of two doses)
A Randomised Stratified Multicentre Phase II Clinical Trial of Single-Agent ADI-PEG 20 (Pegylated Arginine Deiminase) in Patients with Malignant Pleural Mesothelioma.
Jun 2010To assess the time to disease progression between the control group receiving best supportive care and the group receiving ADI-PEG 20 and best supportive care.
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
Jun 2010The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.
PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy
Jun 2010One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer.
Panitumimab in combination with radiotherapy in patients with locally advanced KRAS wildtype rectal cancer (clinical stages II and III)
Jun 2010The primary objective of the study is to estimate the efficacy of panitumumab concurrent to radiotherapy in patients with wild-type KRAS. The rate of pathological complete remissions will be compared to expectations derived from historical data.
Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Jun 2010This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
Jun 2010This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer.
A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects
Jun 2010To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML
May 2010For part A of the study (if applicable): 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and select the feasible dose level for part B 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate. For part B: 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) as regards the selected dose level of lenalidomide 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
May 2010To determine the effectiveness of the combination of bevacizumab and erlotinib as a treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney cancer not associated with HLRCC (or sporadic papillary RCC).
BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor (CONDR)
May 2010The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging (MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research MRI components may be included, these will be analyzed in comparison with pathology results if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This study will create a database of de-identified MRI images which include these techniques so that brain tumors can be studied over time (longitudinally) in an organized manner.
Phase II trial evaluating combined image guided radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder
May 2010Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer.
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (SENSOR)
May 2010To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
Apr 2010This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.
Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial.
Apr 2010To determine the toxicity of adding chloroquine in escalating doses in SCLC patients: to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1, and - to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2
Topical Imiquimod in Treating Patients with Persistent HPV-Infection after Surgical or Radiation Treatment of Cervical Cancer
Apr 2010HPV-clearance 20 weeks after randomization.
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Apr 2010Objectives: 1. To evaluate the natural history of FNMTC. 2. To determine the best screening strategy for FNMTC. 3. To identify genes that may indicate susceptibility to FNMTC.
Chemoradiotherapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery
Apr 2010The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found).
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
Apr 2010The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.
A phase III, double-blind, randomized, controlled study to evaluate the efficacy of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine compared to hepatitis A vaccines as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 15 – 25 years or age.
Apr 2010The primary objectives are to demonstrate efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR) post dose 3 (after Month 6 to Month 48) in adolescent and young adult women who are negative for HPV DNA (by PCR) at Months 0 and 6 for the corresponding HPV type.
Multimodal therapy with and without cetuximab in patients with locally advanced esophageal carcinoma. An open-label phase III trial
Apr 2010Determine the efficacy of neoadjuvant radiochemotherapy (RCT) combined with immunotherapy followed by adjuvant immunotherapy compared with the same schedule without immunotherapy (neoadjuvant and adjuvant).
Stool Testing for Pancreatic Cancer
Apr 2010The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. Investigators hypothesize that analysis of stool samples using digital melt curve (DMC)analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Apr 2010To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. The primary efficacy endpoint of this study is Overall survival
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma.
Apr 2010The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) (phase II)].
Pancreatic Cancer Registry for High Risk Individuals
Apr 2010The aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer
Osteonecrosis in Children With Acute Lymphoblastic Leukemia
Apr 2010Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.
Assessment of Sleep Complaints in Brain Tumor Survivors
Apr 2010Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness.However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors.Children ages 8 to 18 years of age who are active patients in the After Completion of Therapy Clinic and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.
A randomised phase II study of radio-chemotherapy with or without panitumumab (Vectibix®) in irresectable squamous cell carcinoma or adenocarcinoma of the oesophagus (Panoramic)
Apr 2010Description of the 1-year overall survival after chemo-radiation therapy with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for comparison is similar to our success-rate
An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL)
Apr 2010The primary objective of the study is to determine the efficacy, as measured by overall response (complete response [CR] + partial response [PR]), of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin’s Lymphoma (NHL).
Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
Apr 2010The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib).
Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Apr 2010This clinical trial is studying patient, physician, and nurse factors associated with entry onto clinical trials and finishing treatment in patients with primary or recurrent uterine, endometrial, or cervical cancer.
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009)
Mar 2010To compare progression-free survival (PFS) between Arm A and Arm B
A phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma
Mar 2010To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and low human equilibrative nucleoside transporter 1 (hENT1) expression
Seprafilm™ for the Prevention of Intraperitoneal Adhesions and Improved Delivery of Therapy in Women Undergoing Staging and Intraperitoneal Chemotherapy for Advanced Ovarian Cancer
Mar 2010The purpose of this research is to determine if a film to prevent adhesions will improve the area of distribution of a contrast dye (representative of chemotherapy) in the abdominal cavity (belly) of women who have undergone surgery for ovarian cancer as compared with patients who have not had adhesion barrier sheets placed in the belly.
Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma
Mar 2010The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.
Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells
Mar 2010To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
Multicenter phase 2 trial of arq 197 for subjects with relapsed or refractory germ cell tumors
Mar 2010The primary objective is to determine the objective response rate (ORR) after 4 cycles of therapy with ARQ 197 in subjects with GCT.
A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and Imatinib (IM) for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR)
Mar 2010To provide preliminary evidence that HCQ given in combination with imatinib is more effective than imatinib alone in terms of BCR/ABL levels in CML patients who are in major cytogenetic response with residual BCR/ABL+ cells after at least one year of imatinib treatment. To determine the safety and tolerability of HCQ given in combination with imatinib in these patients.
Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia (SNTC)
Mar 2010The study investigates if the sentinel lymphnode (SN) : Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer and Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.
A Cancer Research UK Phase I/IIa Trial of an Oral Notch Inhibitor (MK-0752) in Combination with Gemcitabine in Patients with Stage IV Pancreatic Cancer
Mar 2010The trial is conducted in two phases and the objectives are: in phase I, to recommend a dose for further Phase II evaluation of MK- 0752 in combination with gemcitabine and to determine the safety and tolerability of MK-0752 in combination with gemcitabine in patients with Stage IV pancreatic cancer. In phase II, to measure survival at six months
Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer population
Mar 2010In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily for six months result in a change in volume of prostate cancer, as assessed by MRI (T2 weighted)?
Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma
Mar 2010This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
CIRCCa (Cediranib In Recurrent Cervical Cancer) A Randomised Double Blind Phase II trial of carboplatin-paclitaxel plus cediranib versus carboplatin-paclitaxel plus placebo in metastatic/recurrent cervical cancer
Mar 2010The aim of the study is to provide preliminary evidence regarding whether the addition of cediranib to a combination of carboplatin and paclitaxel will increase progression free survival by 50% in patients with metastatic recurrent cervical cancer.
A Phase 1b/II, Multicenter, Open-Label, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma. Elotuzumab (formerly HuLuc63)
Mar 2010For Phase 1 portion: To identify the maximum tolerated dose of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma. For Phase 2 portion: To evaluate the efficacy of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with multiple myeloma after 1 to 3 prior therapies.
UKALL14 - A randomized trial for adults with newly diagnosed acute lymphoblastic leukemia
Mar 2010To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved event free survival in patients with precursor B-cell ALL (aim 1B). To determine if the addition of nelarabine improves outcome for patients with T cell ALL (aim 1T)
A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
Mar 2010The objective is to compare the efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib (Velcade®) and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
Mar 2010The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Mapatumumab, Cisplatin and Radiotherapy for Advanced Cervical Cancer
Mar 2010In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with locally advanced cervical cancer.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches. To assess the safety and tolerability of imatinib in pediatric patients age 1 to less than 4 during the study period.
Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)
Mar 2010The purpose of this prospective randomized controlled study is to prove the non-inferiority of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of superficial bladder cancer.
Primovist enhanced MRI for the detection and evaluation of focal liver lesions
Mar 2010To determine the diagnostic value of MR-Primovist and Respiratory Triggered DWI MRI for the detection and characterization of focal liver lesions .
Estudio fase II de Bevacizumab en combinación con Capecitabina y radioterapia como tratamiento preoperatorio en pacinetes con cáncer rectal localmente avanzado resecable.
Mar 2010Evaluar la eficacia del tratamiento neoadyuvante con Bevacizumab, administrado bisemanalmente de forma concomitante con capecitabina y radioterapia externa, medida como tasa de respuesta patológica completa.
Brain Metastasis in Breast Cancer Patients
Feb 2010The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
Feb 2010This randomized phase III trial is studying sorafenib tosylate given together with pravastatin to see how well it works compared with giving sorafenib tosylate alone in treating patients with liver cancer and cirrhosis.
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
Feb 2010In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care.
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
Feb 2010To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. The primary efficacy endpoint of this study is Overall survival.
Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer
Feb 2010The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection.
An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with acute lymphoblastic leukaemia.
Feb 2010To characterise the bioavailability of a single 50 mg fixed dose of the O4CP innovative oral liquid formulation versus 50mg registered adult tablets and to assess the pharmacokinetics of an adjusted dose of the O4CP innovative oral liquid formulation given daily for 6 weeks
A Two Part, Phase I-IIa Study Evaluating MK-1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer
Feb 2010Part 1: (1) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. (2) To establish a Phase II / Maximum Tolerated Dose for MK 1775 in combination with topotecan + cisplatin. (3) To determine the preliminary efficacy of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. Part 2: (1) To evaluate the effect of the combination of topotecan/cisplatin + MK-1775 versus topotecan/cisplatin alone on PFS in patients with advanced, metastatic, and recurrent cervical cancer. (2) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer.
A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Feb 2010To establish effectiveness of ofatumumab in combination with bendamustine in patients with indolent B-cell NHL disease relapsed after rituximab therapy
A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation
Feb 2010To assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are • with t(4;14) translocation (Group 1). • without t(4;14) translocation (Group 2).
An Open Label Randomized Controlled Phase lI Trial of Panitumumab in Combination with Epirubicin, Cisplatin and Capecitabine (ECX) versus ECX Chemotherapy alone in Subjects with Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction.
Feb 2010The primary objective is to compare prevalence of pT3/T4 categories (in reference to UICC 2002 criteria, Appendix F) between subjects receiving panitumumab plus epirubicin, cisplatin and capecitabine (ECX) versus subjects treated with ECX chemotherapy alone.
Chemoradiation with gemcitabine in combination with panitumumab for patients with locally advanced pancreatic cancer.
Feb 2010The main objective of the phase 1 part is to determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.
Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design.
Feb 2010To investigate the efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.
Dalteparin in Combination With Sunitinib in Patients With Metastatic Kidney Cancer
Feb 2010To determine the recommended dosage of Sunitinib and Dalteparin in patients with metastatic renal cell cancer. To evaluate the safety and tolerability of combination of Sunitinib and Dalteparin.
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Jan 2010The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
A phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma
Jan 2010To determine the efficacy of RAD001 in patients with progressive irresectable recurrent or metastatic differentiated thyroid carcinoma
Onderzoek naar de farmacokinetiek van uracil na orale toediening bij patiënten met colorectaal carcinoom : KINURA-2
Jan 2010To determine that de PK of an oral uracil loading dose in patients with colorectal cancer and normal DPD activity does not differ from the PK in healthy volunteers.
An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate an Pemetrexed Single Agent given as Neoadjuvant Treatment in Patients with Resectable Rectal Cancer
Jan 2010Evaluation of optimal dose of Methylenetetrahydrofolate (Modufolin) in combination with a fixed dose of Pemetrexed (Alimta) 500mg/m2 related to the safety margins as described.
Genomic Analysis of Pediatric Bone Tumors
Jan 2010To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).
A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer
Jan 2010In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic cancer.
LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)
Dec 2009Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma (SAPHIRE)
Dec 2009The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
A Safety Study of LBH589 (Panobinostat) and RAD001 (Everolimus) to Stabilize Kidney Cancer
Dec 2009This study will see how these two commonly used treatments (Everolimus and Panobinostat) work together in treating kidney cancer
Genetic and Environmental Risk Factors Related to Esophageal Cancer
Dec 2009This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.
M. D. Anderson Symptom Inventory - Ovarian Cancer
Dec 2009The goal of this behavioral research study is to learn more about the kind of symptoms that are experienced by women with ovarian cancer, peritoneal cancer, or fallopian tube cancer.
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma
Dec 2009The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Dec 2009To evaluate the efficacy of pegfilgrastim, as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature ≥ 38.0°C (≥ 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24 hour window of a temperature ≥ 38.0°C or (≥ 100.4°F).
An open-label, multi-center study to evaluate the efficacy of nilotinib in adult patients with gastrointestinal stromal tumors resistant to imatinib and sunitinib
Dec 2009To evaluate the preliminary efficacy of nilotinib in pretreated patients with unresectable or metastatic gastrointestinal stromal tumors. Efficacy is defined as stable disease (SD), partial response (PR) or complete response (CR) during the first 4 months according to RECIST criteria.
Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
Dec 2009The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas
Dec 2009The primary objective of this study is to test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
Dec 2009This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer
Dec 2009The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and temsirolimus will have on thyroid cancer. Treatment guidelines from the National Comprehensive Cancer Network include sorafenib as a treatment option for thyroid cancer.
Prospective multicentric evaluation of a bladder preservation strategy using a combination of neoadjuvant chemotherapy with intensified MVAC (Méthotrexate + vinblastine + adriamicine + Cisplatine) and optimal bladder transurethral resection in patients with a localized muscle infiltrative urothelial carcinoma (protocol ReChiVe)
Nov 2009The 5 years bladder preservation rate in patients with a localized infiltrative bladder treated with a double optimal transurethral bladder resection (TURB) combined with a neoadjuvant chemotherapy.
A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
Nov 2009•To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma •To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Nov 2009This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients (PROTECT-Z)
Nov 2009to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Nov 2009This randomized phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer.
A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia
Nov 2009To determine the maximum-tolerated dose (MTD) in terms of the incidence of dose-limiting toxicity (DLT) of panobinostat in combination with ara-C and mitoxantrone at a fixed dose in adult patients with relapsed or is primary refractory acute myeloid leukemia (AML).
Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives
Nov 2009This clinical trial is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer and their first-degree relatives.
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation
Nov 2009The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Nov 2009Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.
Trial of LBH589 in Metastatic Thyroid Cancer
Oct 2009The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly.
Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study
Oct 2009The principal research question is to determine whether a randomised controlled trial comparing induction chemotherapy followed by oesophagectomy and induction chemotherapy followed by definitive chemoradiotherapy for oesophageal squamous cell carcinoma is feasible in terms of recruiting and randomising sufficient numbers.
A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
Oct 2009To evaluate progression-free survival time of subjects treated with EMD 1201081 + cetuximab compared to cetuximab alone in cetuximab-naïve subjects with recurrent and/or metastatic SCCHN who have progressed on a cytotoxic therapy.
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia
Oct 2009Phase I part: - To assess the MTD and the dose-limiting toxicities (DLTs). Phase II part: - To assess the objective response rate at the recommended dose defined in the phase I part. - To assess the safety and tolerability.
ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study
Oct 2009To assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
Lapatinib and Whole Brain Radiotherapy for patients with brain metastases from lung and breast tumors. A phase II study of the Hellenic Cooperative Oncology Group (HeCOG).
Oct 2009The main objective of the study is to measure the response rate in brain as assessed by volumetric analysis of brain MRI.
Open-Label study of bevacizumab (Avastin®) and taxane monotherapy for the first-line treatment of patients with advanced triple-negative breast cancer
Oct 2009Tolerability and safety profile of bevacizumab when combined with weekly paclitaxel as first line treatment of metastatic triple negative breast cancer.
Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Sep 2009This clinical trial is studying using the lysophosphatidic acid assay to see how well it works in early detection of ovarian cancer in patients with ovarian cancer or who are at risk for ovarian cancer.
Double-blind, placebo-controlled, randomized phase II-study investigating the efficacy of Bevacizumab for symptom control in patients with malignant ascites due to advanced-stage gastrointestinal cancers
Sep 2009To evaluate the paracentesis-free survival (ParFS) following intraperitoneal application of Bevacizumab/Placebo
Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed Head and Neck Cancer
Sep 2009This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
A phase 1b/2 study with the agonistic TRAIL-R1 antibody, mapatumumab, in combination with cisplatin and radiotherapy as a first line therapy in patients with advanced cervical cancer
Sep 2009Phase 1b: To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer. Phase 2: To evaluate the efficacy of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.
Prostate Cancer Symptom Management for Low Literacy Men
Sep 2009This study will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care.
Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer
Sep 2009This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both PAN + pelvis arm and pelvis only arm. This study includes a translational research component in that all the primary tumors are stained with CA9, a hypoxia marker, before randomization. According to our study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). Primary cervical cancer tissues are examined for expression of CA9 just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). We expect a higher benefit of EFI in patients with CA9-positive tumors.
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer
Sep 2009This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer.
A single group trial evaluating one cycle of adjuvant BEP chemotherapy in high risk, stage 1 non-seminomatous germ cell tumours of the testis (NSGCTT)
Sep 2009To show that one cycle of adjuvant BEP chemotherapy results in a 2 year recurrence rate of less than 5% in patients with high-risk stage 1 NSGCTT
A Double-Blind, Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Sep 2009The primary objective of this phase III study in subjects with differentiated thyroid cancer (papillary, follicular, Hurthle cell carcinoma) who are refractory to radioactive iodine treatment is to compare the treatment groups in terms of progression free survival (PFS) evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Phase III Randomized Study of Radiotherapy With Versus Without Temozolomide in Patients With Symptomatic or Progressive Low-Grade Gliomas
Sep 2009Primary Objectives: 1. To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas. 2. To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients.
The effect of drugs used to reverse neuromuscular blockade on intra-cranial pressure
Sep 2009To determine whether sugammadex (Bridion) or neostigmine methylsulphate have any effect on intracranial pressure following elective neurosurgery
MIMEB - Molecular Imaging with erlotinib and bevacizumab. A Phase II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients with Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) treated with Erlotinib and Bevacizumab and to Associate Imaging Findings with Molecular Markers
Sep 2009To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression (CR+PR+SD) after 6 weeks of therapy in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab. To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of PFS in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab.
Pilot study of Lapatinib (Tyverb®) in néoadjuvant treatment for patients with locally bladder carcinoma before cystectomy
Sep 2009The primary objective of the study is to evaluate the effect at a molecular level, of 3 weeks of neoadjuvant lapatinib, in locally advanced muscle-invasive transitional cell carcinoma of the bladder. A comparison of tissue from the original biopsy and cystectomy after lapatinib will allow this to occur. This effect will be evaluated by studying proliferation and apoptotic markers as well as the phosphorylation of proteins which are components of the egf signalling pathway.
Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects
Sep 2009To evaluate the anti-tumor activity of AS703026 combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.
An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN
Sep 2009To determine key pharmacokinetic parameters for zalutumumab as monotherapy in patients with SCCHN.
Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244
Sep 2009The purpose of this study is to find out if the drug AZD6244 can improve the radioactive iodine uptake by the patient's metastatic thyroid cancer.
A Phase II Multicentre Study of perioperative Chemotherapy for resectable Adenocarcinoma of the Gastroesophageal Junction and of the Stomach
Aug 2009Collection of the R0 resection rate
Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Aug 2009The purpose of this study is: To evaluate the utility of F-18-FCH-PET/CT and MR imaging with 3-D MR spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current standard work-up using TRUS-guided biopsy. All imaging findings will be correlated with "gold standard" step slice histological examination. The hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach. To evaluate FCH-PET for the restaging of prostate cancer after biochemical relapse in a large patient cohort. This will run in parallel to the work-up of primary prostate cancer, as the FCH radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18-FCH-PET/CT for these patients and this indication is currently not reimbursed by Swiss obligatory health insurance providers.
Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer
Aug 2009This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works compared with giving paclitaxel together with ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine or ovarian cancer.
Phase III Randomized Study of Paclitaxel With Carboplatin Versus Ifosfamide in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV Persistent or Recurrent Uterine or Ovarian Carcinosarcoma
Aug 2009To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma.
An open-label Phase IIa, non-randomised, study of Alpharadin in breast cancer patients with bone dominant disease who are no longer considered suitable for endocrine therapy
Jul 2009To investigate if multiple intravenous injections of Alpharadin have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy.
A Randomized Phase III Trial Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck
Jul 2009To compare the 3-year survival achieved by Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck [SCCHN].
Phase II/III Randomized Study of Lapatinib Ditosylate in Patients With HER1- and/or HER2-Overexpressing Stage IV Transitional Cell Carcinoma of the Bladder
Jul 2009Compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.
Motion Correction in Dynamic Contrast Enhanced Magnetic Resonance Imaging (MRI) in Ovarian Cancer: A Pilot Study
Jul 2009The purpose of this study is to develop new image analysis method using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer
A multicenter, open label, phase I / II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients.
Jul 2009Phase I part of study:To identify the maximum tolerated dose (MTD) of BIBF 1120 in terms of drug-related adverse events in HCC patients. Phase II of study:To evaluate the efficacy of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.
A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistant Prostate Cancer That Have Received Prior Treatment with Docetaxel. Revised Protocol 05 incorporating Protocol Amendments 04, 09, 11,12 and 14 + Biomarker Amendment 06 (version 1.0 dated 16-Nov-09) - Site Specific + Serum Biomarker Amendment 13 (Version 1.0 dated 18-Mar-11) - Site Specific
Jul 2009To compare overall survival of subjects with castration resistant prostate cancer (CRPC), that have progressed during or following docetaxel treatment, when randomized to treatment with bone-directed radiotherapy followed by ipilimumab vs bone-directed radiotherapy followed by placebo.
Evaluation of the safety and efficacy of WST11 mediated vascular targeted photodynamic therapy on obstructing endobronchial Non-Small Cell Lung Cancer
Jul 2009To determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using vascular targeted photodynamic therapy (VTP) in obstructive non-small cell lung cancer.
A single arm, open-label trial assessing the effect of Capecitabine (Xeloda®) on progression-free survival rate at four months in breast cancer patients with CNS progression after whole brain radiotherapy
Jul 2009To evaluate the efficacy of capecitabine in terms of Progression Free Survival (PFS) rate at 4 months, reviewed by centralized independent expert, in treatment of brain metastases secondary to breast cancer in patients with CNS progression after whole brain radiotherapy (WBRT).
Radiation therapy and concurrent plus adjuvant Temsirolimus (CCI-779) versus chemo-irradiation with Temozolomide in newly diagnosed glioblastoma without methylation of the MGMT gene promoter – a randomized multicenter, open-label, Phase II study
Jul 2009The study’s primary objective is to document the activity profile of CCI-779 by the evaluation of OS12 in patients with newly diagnosed glioblastoma (GBM) without methylation of the MGMT gene promoter, treated with CCI-779 before and concomitantly to RT, followed by CCI-779 maintenance therapy.
El-porCEA: Assessment of safety and immunogenicity of intradermal electroporation of tetwtCEA DNA in patients with colorectal cancer.
Jun 2009To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation
Significance of prognostic and predictive factors for the efficacy and safety of neoadjuvant chemotherapy in combination with chemoradiation administered in patients with locally advanced cervical cancer.
Jun 2009The main objective are: 1. To evaluate the efficacy of treatment with neoadjuvant cisplatin+gemcitabine based chemotherapy and with concurrent cisplatin+gemcitabine+radiotherapy in locally advanced cervical cancer (defined as response to treatment and progression free survival); 2. To evaluate treatment safety.
Ixabepilone to Treat Cervical Cancer
Jun 2009Objective is to determine whether ixabepilone is effective for treating cervical cancer.
Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer (CA9CRM)
Jun 2009The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy. The investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer.
An International Study on Magnetic Resonance Imaging (MRI)-Guided Brachytherapy in Locally Advanced Cervical Cancer (EMBRACE)
Jun 2009Aims: To introduce MRI based 3D-4D BT in locally advanced cervical cancer in a multicenter setting within the frame of a prospective observational study. To establish a bench-mark for clinical outcome with image based BT in a large patient population with respect to local control, survival, morbidity and QoL. To establish a reference material with regard to image based DVH parameters according to the guidelines from the GEC ESTRO working group. To correlate image based DVH parameters for CTV and for OAR with outcome. To develop prognostic and predictive statistical models for clinical outcome including volumetric, dosimetric, clinical and biological risk factors. To establish radiobiological parameter estimates that will allow a precise risk estimation in individual patients and aid in the development of new treatment protocols.
Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology.
Jun 2009In patients with medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]: to determine the effect of E7080 on the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) by independent imaging review (IIR).
Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation
Jun 2009To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.
High-dose Chemotherapy for Poor-prognosis Relapsed Germ-Cell Tumors
Jun 2009The goal of this clinical research study is to learn if bevacizumab, when given in combination with 2 cycles of high-dose chemotherapy, can help to control germ-cell tumors.
Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
Jun 2009The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the malignant tumor, by means of surface, insulated electrodes.
Étude multicentrique de phase Ib-II en escalade de dose de la trabectédine (Yondelis®) en association avec l’oxaliplatine chez des patientes atteintes d’un cancer de l’ovaire avancé prétraité.
Jun 2009Phase Ib stage: To determine the recommended dose (RD) of the combination of trabectedin and oxaliplatin in patients with advanced ovarian cancer. Phase II stage: To determine the antitumor activity of the combination of trabectedin and oxaliplatin, administered at the RD established in the phase Ib stage, in patients with advanced ovarian cancer.
Exploratory study to assess the predictive value of 99mTc-labeled albumin spheres for the intrahepatic distribution of 90Y SIR Spheres in patients with liver metastases of colorectal tumors.
Jun 2009To assess the predictive value of MAA injected into the common hepatic artery for the distribution of 90Y SIR-Spheres
A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy
May 2009To compare overall survival between RAD001+best supportive care (BSC) and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
A multi-center, open label Phase II trial of TKI258 in FGFR1 amplified and non-amplified metastatic HER2 negative breast cancer.
May 2009The purpose of this study is to determine the Overall Response Rate (ORR) in 4 groups of patients with (FGFR1+, HR+),(FGFR1+, HR-),(FGFR1-, HR+) or (FGFR1-, HR-) breast tumors treated with TKI258.
Vascular-targeted photodynamic therapy using WST11 in patients with localised prostate cancer
May 2009To determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer with both normal (<60cc) and high-volume prostates (≥60cc).
Non-invasive detection of prostate cancer using functional MRI in patients with histopathologically confirmed prostate cancer before prostatectomy
May 2009The main object of the trial is to assess the diagnostic value of functional MRI (T2+DCE MRI) for the detection of prostate cancer (on the basis of 16 prostate segments) and to show superiority in the accuracy to detect prostate cancer compared to conventional T2 MRI (SOR: histopathology)
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
May 2009This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer (SN-FNAC)
May 2009The primary objective is to evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy. While the secondary objectives are to evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy, and evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.
Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients with Locally Advanced Rectal Cancer
May 2009To investigate the antitumor activity of panitumumab in combination with preoperative external beam radiotherapy in patients with locally advanced rectal cancer, followed by surgery and adjuvant chemotherapy.The primary objective is the complete pathological response of the tumor.
A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or without Obatoclax Administered Every 3 Weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
May 2009Phase I: Determine the recommended Phase II dose of obatoclax administered as a 3-hour infusion on 3 consecutive days and, in a separate obatoclax dose escalation, as a 72-hour infusion, every 21 days in combination with carboplatin and etoposide. Phase II: Compare the overall response rate of the 2 treatment arms (• Carboplatin, etoposide, and obatoclax as a 3-hour infusion on 3 consecutive days, or • Carboplatin and etoposide alone)
A randomized phase II study of oxaliplatin and capecitabine combination vs irinotecan and capecitabine combination for the treatment of elderly patients with advanced colorectal cancer.
May 2009The objective of this study is to compare the effectiveness of oxaliplatin and capecitabine combination vs irinotecan and capecitabine combination for the treatment of elderly patients with advanced colorectal cancer.
Studying Biomarkers in Patients With Pancreatic Cancer
May 2009This research study is looking at biomarkers in patients with pancreatic cancer.
Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer
May 2009This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
May 2009This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
May 2009The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.
Intravenous Iron: biomarkers and treatment strategies in anaemic Colorectal cancer patients.
May 2009Does the use of intravenous iron provide a safe and effective treatment for anaemia in surgical patients and does the use of intravenous iron lead to a reduction in allogenic blood transfusion?
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma
May 2009To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
May 2009To assess the efficacy, in the IA population, of RO5217790 compared to placebo in achieving histologic resolution at Month 6 (determined by evaluation of tissue derived from surgical excision of the entire lesion area). Full analysis: To assess the efficacy of RO5217790 compared to placebo in achieving histologic resolution at Month 6 (determined by evaluation of tissue derived from surgical excision of the entire lesion area) in patients with CIN2/3 associated with HPV16 single infection i.e. stratum 1
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Locally Advanced Cervical Cancer
Apr 2009To determine the objective response rate (ORR) with NKTR-102 given on one of two schedules: once every 14 days (q14d) and once every 21 days (q21d)
A phase II international multicentre randomised open label study of oral steroid sulphatase inhibitor BN83495 versus megestrol acetate (MA) in women with advanced or recurrent endometrial cancer
Apr 2009To determine the antitumour efficacy of BN83495 measured by the percentage of women with advanced or recurrent endometrial cancer who have neither progressed nor died after 6 months of treatment.
Phase III Randomized Study of Radiotherapy Alone Versus Radiotherapy With Concurrent and Adjuvant Temozolomide Versus Temozolomide Alone in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Glioma
Apr 2009The primary objective of this trial is to determine whether there is a survival advantage for patients with newly diagnosed 1p/19q codeleted anaplastic glioma who receive concurrent temozolomide and radiotherapy (RT) followed by adjuvant temozolomide over that observed in patients treated with RT alone (control).
A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination with Chemotherapy as First-line Therapy in Subjects with Advanced Gastric Cancer
Apr 2009To assess the Progression-free survival (PFS)
A Randomized Phase II Study Of Carboplatin And Paclitaxel +/- Cetuximab, In Advanced And/Or Recurrent Cervical Cancer
Apr 2009To assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).
A Phase II study in patients with locally advanced pancreatic carcinoma: ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin
Apr 2009To assess if the addition of nelfinavir to gemcitabine and cisplatin chemoradiotherapy improves survival and merits further study.
Phase II Trial of the effect of Gemcitabine with intravenous omega 3 fish oil infusion in patients with unresectable pancreatic adenocarcinoma
Apr 2009Objective response rate (complete + partial response) of response of patients receiving gemcitabine plus parenteral omega-3.
Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients
Apr 2009The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.
Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
Apr 2009The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response
A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.
Apr 2009To evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves the progression free survival.
Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
Apr 2009A retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings: Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy (about 100 patients) Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100 patients)
A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)
Mar 2009Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
Pharmacokinetic Study of Capecitabine After Total Gastrectomy for Stomach Adenocarcinoma
Mar 2009The purpose of this study is to evaluate the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Evaluation of Non-Invasive Assay(s) for the Detection of Bladder Cancer
Mar 2009The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of bladder cancer progression. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence.
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC) (SBRT-NSCLC)
Mar 2009The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.
Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Mar 2009This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Open-label, phase II, randomized, comparative, multicentre trial of concurrent Whole Brain Radiation Therapy (WBRT) and capecitabine (Xeloda®) followed by maintenance capecitabine compared with standard WBRT in breast cancer patients with newly diagnosed brain metastasis
Mar 2009To demonstrate the superiority of WBRT with concurrent capecitabine followed by maintenance capecitabine versus WBRT in best objective CNS response (CR + PR) in breast cancer patients with newly diagnoses CNS metastasis.
A Randomized Discontinuation Phase II Trial of Deforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients with KRAS Mutations
Mar 2009To determine the efficacy of deforolimus in patients with KRAS mutant NSCLC who have progressed after two prior chemotherapy regimens compared to placebo by progression free survival analysis of randomized patients who have stable disease after an 8-week lead-in treatment with deforolimus.
Phase II Study of Oxaliplatin / Irinotecan / Bevacizumab Followed by Docetaxel / Bevacizumab in Inoperable Locally Advanced or Metastatic Gastric Cancer Patients
Mar 2009The primary objective of this study is to determine the efficacy of an Oxaliplatin / Irinotecan / Bevacizumab therapy followed by Docetaxel / Bevacizumab therapy followed by Bevacizumab until progression in the treatment of locally advanced metastatic gastric cancer, in terms of response rates (complete or partial response, determined by radiologic evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST)).
Weekly vs every 3 week carboplatin + paclitaxel in patients with ovarian cancer : randomized multicenter study
Mar 2009The primary objective of the study is to compare the effects on quality of life in patients receiving the experimental combination of weekly carboplatin and paclitaxel or the standard combination of every 3 week carboplatin and paclitaxel as first line therapy for ovarian, fallopian tube or primary peritoneal cancer
An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML)
Mar 2009The primary objective of the trial is to determine the complete response rate (CR/CRi) of older patients with relapsed or refractory AML when given 1 or 2 courses of low-dose Clofarabine combined with Temsirolimus.
A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA) versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
Mar 20092 years diease free survival following first remission achievement (CR or CRp) in younger patients with intermediate-risk or unfavorable-risk AML
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Feb 2009Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer (OPEN)
Feb 2009The purpose of this study is to compare enteral nutrition along with standard post-surgery care against current standard post-operative care alone.
CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.
Feb 2009To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Feb 2009The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses.
Stealth liposomal doxorubicin vs carboplatin/paclitaxel in patients with ovarian cancer recurrence between six and twelve months after previous platinum based chemotherapy: phase III multicenter randomized study
Feb 2009(i) To test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative. (ii) To evaluate if the sequence of stealth liposomal doxorubicin followed at a later progression by carboplatin/paclitaxel is superior to the inverse sequence of treatment (carboplatin/paclitaxel followed at a later progression bu stealth liposomal doxorubicin). The primary endpoint is overall survival.
A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Women.
Feb 2009To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine when administered to 16- to 26-year-old women.
Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Feb 2009This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
Gemcitabine combined with the mTOR inhibitor Temsirolimus (CCI-779) in patients with inoperable or metastatic pancreatic cancer
Feb 2009The primary objective of this study is to determine the maximum tolerated dose and recommended phase II dose of temsirolimus and gemcitabine in patients with pancreatic cancer, and to estimate the progression free survival in patients treated with the temsirolimus+gemcitabine combination.
Genetic Susceptibility to Bladder Cancer
Feb 2009This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. We propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens.
An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin During Pregnancy or Within 6 Months Prior to Conception
Jan 2009The Herceptin Pregnancy Registry is a U.S.-based, prospective, observational cohort study established to obtain data on pregnancy outcomes in women with breast cancer who were treated with a Herceptin-containing regimen during pregnancy or within 6 months prior to conception.
Topical Imiquimod in Treating Patients with Grade 2/3 Cervical Intraepithelial Neoplasia
Jan 2009To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3.
Concomitant Tarceva® and irradiation in patients in local-regionally advanced non-small cell lung cancer. A phase II study
Jan 2009The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week)
A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
Jan 2009This 6 arm study will assess the safety and efficacy of RO5072759 given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine, cyclophosphamide) or bendamustine chemotherapy in patients with CD20+ B-cell follicular non-Hodgkin's lymphoma. Patients with relapsed or refractory disease will be assigned by physician choice to either the CHOP treatment arm, to receive a maximum of 8x3weekly cycles of treatment, or the FC treatment arm, to receive a maximum of 6x4weekly cycles of treatment, and will then be randomized to receive combination treatment with RO5072759 either at a dose of 400 mg iv for all infusions, or at a dose of 1600 mg iv for the first 2 infusions, followed by 800 mg for all subsequent infusions. Previously untreated patients will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in combination with bendamustine. The anticipated time on study treatment is 3-27 months.
Spousal Support in Head and Neck Cancer
Jan 2009To examine the associations between emotional disclosure, social constraints/support and patient/spouse cognitive processing in Head and Neck Cancer (HNC) using self-report and observational methods.
A Phase 1 Trial of Verteporfin Photodynamic Therapy in Unresectable Pancreatic Carcinoma (VERTPAC-01 study)
Jan 2009The trial aims to investigate the safety and efficacy of verteporfin photodynamic therapy in patients with locally advanced pancreatic carcinoma. The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy.
Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN
Jan 2009Evaluation of efficacy of the following two treatments for usual type VIN: -Vaccination + imiquimod: Vaccination with Gradasil, followed by local applications of imiquimod 5% cream, and -Imiquimod alone: Placebo vaccination (saline) followed by local applications of imiquimod 5% cream.
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Dec 2008Investigators thus plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.
Chemoradiation combined with panitumumab followed by surgery for patients with operable esophageal cancer
Dec 2008A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in our trial we will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2008All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)
Dec 2008Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.
Cisplatin and docetaxel followed by short-course of radiotherapy and consolidation chemotherapy with ciplatin and docetaxel in inoperable non small cell lung cancer (NSCLC-stage III).
Dec 2008The primary end-point of this study is to evaluate the activity of the Cisplatin/Docetaxel in association with short-course of radiotherapy in patients with locally advanced and inoperable NSCLC.
Radical Trachelectomy for Cervical Cancer
Dec 2008The primary objective of this study is to longitudinally assess quality of life, sexual functioning, symptoms, and satisfaction with healthcare decisions in women who have undergone abdominal radical trachelectomy for cervical cancer. The secondary objectives are: To determine long-term fecundity and pregnancy outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, to determine short- and long-term operative outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, and to determine disease-free and overall survival in women who have undergone abdominal radical trachelectomy for cervical cancer.
Evaluation of the preventive effect of enoxaparin, pentoxiphylline and ursodeoxycholic acid to radiation induced liver toxicity after brachytherapy of liver metastates from colorectal carcinoma, assessed in a prospective randomised trial.
Dec 2008To assess if a combination regimen of pentoxiphylline, low dose low molecular weight heparin and ursodeoxycholic acid provides a preventive effect regarding irradiation damage to liver parenchyma after HDR-brachytherapy.
Florida Center for Brain Tumor Research (FCBTR)
Dec 2008The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and cures for brain tumors.
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
Dec 2008The primary objective is to compare the treatment groups in terms of progression free survival (PFS) which in this setting is based on time to CT-documented relapse.
Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
Dec 2008This clinical trial is studying an autoantibody blood test in finding metastasis in patients with localized or metastatic kidney cancer.
A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Dec 2008To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping adjuvant treatment with imatinib.
High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors
Nov 2008Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor; High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation; High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment
A Phase II Study of Oral Panobinostat in adult patients with Relapsed/Refractory classical Hodgkin’s Lymphoma after High-dose Chemotherapy with Autologous Stem Cell transplant.
Nov 2008To determine the objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL using modified response criteria for malignant lymphoma
Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
Nov 2008In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase
An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
Nov 2008To evaluate progression free survival (PFS) with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced or metastatic medullary thyroid carcinoma (MTC).
Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients
Nov 2008Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) & 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.
Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapse
Oct 2008To assess the therapeutic activity of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse.
Cancer Oesophagus Gefitinib(COG) - Phase III randomised, double-blind, placebo-controlled trial of gefitinib (Iressa®) versus placebo in oesophageal cancer progressing after chemotherapy.
Oct 2008To assess whether gefitinib will improve overall survival in patients with oesophageal cancer when compared to a placebo.
A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer.
Oct 2008To assess the objective response rate by volumetric analysis of the combination lapatinib and capecitabine on brain metastasis as assessed by MRI, in metastatic HER2 positive breast cancer patients, prior to any brain radiotherapy.
Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer
Oct 2008The main objectives are response rate and time to progression
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Oct 2008The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
A phase II trial to assess the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adenocarcinomas.
Oct 2008Evaluation of the efficacy of efavirenz as second-line monotherapy for the treatment of advanced pancreatic adeno-carcinomas in terms of non-morphological progression at 2 months.
A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advanced transitional carcinoma of the urothelium.
Oct 2008The objective of this trial is to assess whether the addition of sunitinib to standard cisplatin / gemcitabine (CG) cancer chemotherapy improves outcome for participants with advanced cancer of the urinary system (urothelial cancer). The primary objective is to assess the activity, safety and feasibility of using the 3−drug combination (SCG) in patients with advanced transitional cell carcinoma of the urothelium. The primary outcome measure is progression−free survival (PFS) at 6 months from date of enrolment. This is the proportion of participants who are alive at 6 months without disease progression, according to RECIST (Response Evaluation Criteria In Solid Tumours).
A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer - a Window-of Opportunity Study
Oct 2008The primary objective of the current study is to evaluate statin induced effects on tumour proliferation response.
Multicenter phase III randomized study of cisplatin and etoposide with or without bevacizumab as first-line treatment in extensive stage (ED) small cell lung cancer (SCLC)
Oct 2008To compare overall survival (OS) between the combination cisplatin (25 mg/m2 i.v. on day 1-3) + etoposide (100 mg/m2 i.v. on day 1-3) + bevacizumab (7.5 mg/kg i.v. on day 1) given every 3 weeks (experimental arm) and cisplatin (25 mg/m2 i.v. on day 1-3) + etoposide (100 mg/m2 i.v. on day 1-3) alone given every 3 weeks (control arm) in previously untreated patients with extended SCLC.
Neoadjuvant epirubicin-oxaliplatin-xeloda and oxaliplatin-xeloda-radiotherapy in locally advanced, resectable, gastric cancer. a phase II collaborative study
Oct 2008The pathological complete response rate of this neoadjuvant chemo-radiotherapy program in operable locally advanced adenocarcinoma patients
New therapeutic approaches for anaplastic thyroid cancer: assessment of the benefit-risk profile of the combination valproic acid-paclitaxel.
Sep 2008Evaluation of the antitumour efficacy of valproic acid and paclitaxel in patients with undifferentiated thyroid cancer
Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkins lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients.
Sep 2008To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET-2 positive), can be salvaged with an early shift to high-dose chemotherapy supported by stem cell rescue.
Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
Sep 2008This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer.
Estudio fase II, de la combinación de Oxaliplatino y Sorafenib en pacientes con Adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado o metastásico, en progresión tras un esquema basado en cisplatino.
Sep 2008Determinar la eficacia de tratamiento
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
Sep 2008The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.
Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib (OPEN)
Sep 2008The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors.
A phase I/II trial testing nelfinavir, an inhibitor of Akt signaling, in combination with preoperative chemoradiotherapy in patients with locally advanced rectal cancer
Sep 2008To investigate the safety and the activity of nelfinavir, administered before and during preoperative chemoradiotherapy, 28x1.8 Gy in combination with Xeloda 825 mg/m2 BID, in patients with locally advanced rectal carcinoma.
Phase III Randomized Chemoprevention Study Of Selenium On The Recurrence Of Non-Invasive Bladder Cancer
Sep 2008The primary objective of the study is to determine the effect of selenium, in addition to standard care, on the recurrence of bladder cancer.
New conservative therapies in Retinoblastoma: direct intraarterial (ophtalmic artery) chemotherapy with Melphalan for intraocular retinoblastoma
Sep 2008Definition of a microtheterization angiographic technique to repeatedly selective cannulation of the ofthalmic artery in RTB patients. Selective intraocular infusion of an active and effective chemotherapeutic agent in advanced RTB.
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
Sep 2008The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).
A randomized phase II of bevacizumab, capecitabine and radiation therapy with or without oxaliplatin in the preoperative treatment of locally advanced rectal cancer
Sep 2008This phase II trial assesses the activity of bevacizumab (Avastin) in combination with capecitabine (Xeloda) and radiation therapy with or without oxaliplatin (Eloxatin) in the pre-operative treatment of locally advanced rectal cancer, followed by TME resection, in a multicenter setting.
Quality of Life in Patients With Bladder Cancer
Aug 2008The purpose of this study is to learn about the quality of life of people living with bladder cancer. We are interested in learning about how the treatments for bladder cancer affect people. We plan to use the findings from this study to help doctors provide better care and information to patients with bladder cancer.
A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (sequential high dose cytosine arabinoside and mitoxantrone) versus Standard Double Induction for Initial Chemotherapy of Adult Patients with Acute Myeloid Leukemia
Aug 2008Overall response rate (ORR), aiming at a 15% increase in the CR (complete remission)/CRi (incomplete peripheral recovery) rate by S-HAM induction versus conventional double induction [TAD – HAM for younger patients, HAM (- HAM) for elderly patients].
mEOC: A GCIG Intergroup multicentre trial of open label carboplatin & paclitaxel +/- bevacizumab compared with oxaliplatin & capecitabine +/- bevacizumab as first line chemotherapy in patients with mucinous Epithelial Ovarian cancer (mEOC)
Aug 2008To determine whether a chemotherapy regimen of oxaliplatin and capecitabine improves overall survival compared to conventional chemotherapy with carboplatin and paclitaxel in patients with advanced mucinous carcinoma of the ovary. In addition, the trial aims to investigate whether the addition of bevacizumab to chemotherapy improves overall survival in these patients.
Preoperative Radiotherapy and Local Excision in Rectal Cancer
Aug 2008The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.
Computer Tools for Improving Early Diagnosis and Treatment in Healthy Volunteers or Patients With Pancreatic Cancer or Who Are At Risk For Pancreatic Cancer or Who Have a Noncancer Pancreatic Disorder
Aug 2008This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder.
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Aug 2008This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Aug 2008This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.
The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Jul 2008The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters.
Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study.
Jul 2008To assess the complete cytogenetic response rate at 12 months
A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer
Jul 2008Determination of the potentiality of SonoVue to guide prostate biopsy increasing the detection rate of malignant lesions of 6% points in absolute terms compared to the detection rate of the conventional systematic biopsy on patients candidates to a bioptic procedure. The study population comprises both candidates to a first bioptic exam and candidates to a second bioptic procedure having had a previous negative result independently from the present study.
A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatib) in Reducing the Risk of Bone Metastases and Prolonging Disease-Free Survival in Women with Breast Cancer
Jul 2008The main objectives of the trial are: To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing a first bone metastasis (first disease recurrence) compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily on disease-free survival compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 250 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo. To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo
A prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment
Jul 2008The objective is to compare the safety and efficacy of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer (RASTEN)
Jul 2008The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.
Randomized placebo-controlled phase III trial of low-dose tamoxifen women whit IntraEphitelial Neoplasia(IEN)
Jul 2008The primary endpoint of the proposed trial is to assess if tamoxifen at a low dose, 5mg/day, reduces the incidence of invasive breast cancer and ductal carcinoma in situ (DIN 1c, 2, 3) of the breast, in women operated on for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN1b, DIN 2, DIN3, 1a excluded) of the breast.
Randomized prospective phase II study of temsirolimus with or without low-dose interferon alpha in metastatic non-clear renal cell carcinoma: GOIRC study 02/2008
Jul 2008The main objective of this trial is to assess Overall Response Rate (RECIST Criteria); Time to Progression (TTP); Safety; Overall Survival (OS).
A phase II multi-center, open-label, study of Nilotinib at a dose of 300mg twice daily in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Jul 2008To establish the Complete Cytogenetic Response Rate at 6 months.
Sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in locally advanced or metastatic Non Small-Cell Lung Cancer
Jul 2008To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy
ALFA 0703 : A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Chemotherapy or azacitidine as salvage therapy and Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML)
Jun 2008Untreated AML patients aged more than 65 will be subjected to two randomizations (R1 and R2), in this study. The primary objective of the first randomization (R1) is to assess the benefit in terms of Event Free Survival (EFS) of untreated AML patients aged more than 65 years, treated with induction and consolidation chemotherapy courses, in one arm or with the same chemotherapy courses combined with ATRA in the other arm. The primary objective of the second randomization (R2) is to assess the benefit in terms of Relapse Free Interval (RFI) of maintenance with azacitidine in AML patients in CR, after induction and 4 to 6 consolidation courses of chemotherapy +/- ATRA.
Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients
Jun 2008This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)
Jun 2008The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).
Accelerated growth of synchronous colorectal liver metastases: effects of neo-adjuvant therapy
Jun 2008To obtain proof of principle that outgrowth of metastatic disease in colorectal cancer, as observed after resection of the primary tumour, can be influenced by pre-operative treatment ( before resection of the primary tumour) with the anti-angiogenic agent bevacizumab
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
Jun 2008A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.
Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer
Jun 2008The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when combined with carboplatin plus etoposide. The Phase II portion is to determine progression-free survival among patients with extensive disease small cell lung cancer receiving carboplatin plus etoposide with vorinostat.
Phase II multicentre clinical study with early treatment intensification in pts with high-risk hodgkin lymphoma, identified as FDG-PET scan positive after two conventional ABDVD courses
Jun 2008Main objective of the trial is to assess the 3years PFS
Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients
May 2008The purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. Conventional methods such as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict chemotherapy response in osteosarcoma.
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
May 2008To determine whether single agent larotaxel increases overall survival when compared to continuous administration of 5-Fluorouracil (5-FU) in patients with advanced pancreatic cancer previously treated with a gemcitabine-based therapy
Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer
May 2008RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer. PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.
Open-label, randomized, controlled Phase I/II study of cilengitide to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-FU, and cetuximab in subjects with recurrent/metastatic squamous cell cancer of the head and neck.
May 2008Phase I part: safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU. Phase II part: Progression Free Survival
Phase III Randomized Study of Sunitinib Malate as Maintenance Therapy in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Combination Chemotherapy
May 2008To compare the effect of sunitinib malate vs placebo on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer who have stable or responding disease after prior treatment with 4 courses of platinum-based therapy.
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy
May 2008The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/square metre administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan (1.5 mg/square metre administered as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course) in patients with extensive or limited and sensitive or refractory small cell lung cancer (SCLC) after failure of first-line chemotherapy.
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Apr 2008The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia or lymphoblastic lymphoma.
Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)
Apr 2008The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.
An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Apr 2008To determine the efficacy of 0.10 mg/kg and 0.25 mg/kg ABT-869 using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and to establish the safety/tolerability profile of ABT-869 in subjects with advanced or metastatic NSCLC.
Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)
Apr 2008To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in patients with locally advanced rectal cancer.
Sutent Adjunctive Treatment of Differentiated Thyroid Cancer (IIT Sutent)
Apr 2008This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates.
A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer (BCCR)
Apr 2008This clinical trial is gathering information about patients with breast cancer and their families.
Activity of sunitinib in esophageal cancer, melanoma and sarcoma
Apr 2008Evaluate the objective respons rate as defined by the RECIST method for patients with advanced esophageal cancer, melanoma and sarcoma.
Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer
Apr 2008To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Apr 2008The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
Apr 2008This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life.
Apr 2008The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.
Trial SAKK 56/07 Dasatinib first-line treatment in gastrointestinal stromal tumors. A multicenter phase II trial.
Apr 2008Efficacy of dasatinib treatment as assessed by fusion PET/CT-scan
A randomized phase III study of follow up with or without adjuvant Gefitinib (IressaTM) following chemotherapy in patients with advanced non-small cell lung cancer
Mar 2008To demonstrate in a prospective way a benefit in terms of overall survival and progression-free survival of Gefitinib (ZD1839, IressaTM) compared to placebo in patients with advanced non small cell lung cancer (NSCLC), who are not progressing on first line palliative induction chemotherapy.
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Mar 2008The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Treatment Monitoring of Advanced Colorectal cancer with 18F-FDG PET/CT
Mar 2008The objective of this study is to assess the efficacy and safety of 18F-FDG PET/CT in the treatment of patients with colorectal cancer.
A Phase 2, Single-Arm Study of Pralatrexate in Patients with Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
Mar 2008To determine the objective response rate (CR + PR) for pralatrexate with concurrent vitamin B12 and folic acid supplementation in the treatment of patients with advanced or metastatic relapsed TCC (Transitional Cell Carcinoma) of the urinary bladder.
A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases.
Mar 2008To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).
Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Mar 2008This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.
A randomised open-labelled multicentre trial of the efficacy of epirubicin, oxaliplatin and capecitabine (EOX) with or without panitumumab in previously untreated advanced oesophago-gastric cancer (REAL3)
Feb 2008To determine whether adding panitumumab to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the median overall survival of patients with advanced oesophago-gastric cancer.
A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia
Feb 2008To determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL paitent and to confirm safety and efficacy of veltuzumab that was previously established when administered intravenously.
Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
Feb 2008This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study.
Feb 2008The main objective to the trial is response rate.
Pazopanib in Treating Patients With Advanced Thyroid Cancer
Feb 2008This phase II trial is studying the side effects and how well pazopanib works in treating patients with advanced thyroid cancer.
A phase II, double-blind, placebo controlled, randomised study to assess the efficacy and safety of 2 doses of ZACTIMA (ZD6474) in combination with FOLFIRI vs. FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen
Feb 2008The primary objective of this study is to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with FOLFIRI versus FOLFIRI alone for the treatment of patients with colorectal cancer that have failed prior treatment with oxaliplatin and a fluoropyrimidine by assessment of disease progression.
A phase II study of metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with bevacizumab and erlotinib (BEXE), plus trastuzumab in HER2/neu positive tumors (BEXET), in advanced breast cancer
Feb 2008Main objective of the trial is to assess the activity of the proposed regimen.
A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancer
Feb 2008The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival.
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia
Feb 2008To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML.
A Phase II, Randomised, Open-label, Pilot Study to Evaluate the Safety and the Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone Disease
Feb 2008To estimate the effect of AZD0530 plus standard of care (SoC) compared with zoledronic acid plus SoC on bone resorption by assessment of serum beta Cterminal cross-linking telopeptide of Type I collagen (βCTx)
Phase III Study of Multimodality Therapy Comprising Induction Chemotherapy, High-Dose Consolidation Chemotherapy, Autologous Stem Cell Transplantation, and/or Radiotherapy in Children With Extraocular Retinoblastoma
Feb 2008- To estimate the proportion of children with extraocular retinoblastoma who achieve long-term event-free survival after treatment with aggressive multimodality therapy compared to historical controls. - To estimate the response rate to the induction phase of the regimen. - To evaluate the toxicities associated with this regimen.
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC 04407)
Feb 2008The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone
Feb 2008Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.
A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Jan 2008Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.
Phase 2 trial with Avastin and Doxorubicin postoperatively for patients with anaplastic thyroid carcinoma
Jan 2008To assess overall survival and response rate (recist)
Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
Jan 2008The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatments.
Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
Jan 2008The clinical study is a Phase II, randomized, double-blinded, placebo-controlled trial in men 30-80 years of age with biopsy proven HGPIN or atypical small acinar proliferation (ASAP) and no evidence of prostate cancer, prostatitis or urinary tract infection. A total of 272 men will be randomized to the study, with the goal of completing 240 evaluable participants. Participants who consent to the study and meet initial eligibility criteria will be undergo a one-week run-in period during which they will be asked to self-administer the supplement daily as well as complete study logs and two-day diet recall forms. Participants must meet all inclusion criteria and remain compliant during the run-in period to be randomized to a treatment arm. Participant will complete a quality of life (QOL) survey and have blood collected for baseline tests. Participants will be equally randomized (n=136 per arm) to blinded treatment with either Polyphenon E 200 mg epigallocatechin gallate (EGCG) twice a day (bid) or matching placebo. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and other and lower urinary tract symptom (LUTS) and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood and urine will be collected, and repeat digital rectal exam (DRE) and prostatic specific antigen (PSA) will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat biopsy will be performed. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. The primary endpoint of the study is a comparison of the incidence of prostate cancer between participants in the treatment vs. placebo arm; in addition, the prevalence of HGPIN or ASAP in pre-treatment and post-treatment biopsies in participants treated with Polyphenon E vs. placebo will be compared. If participants develop prostate cancer during the course of the study, the extent and grade of cancer will be assessed and compared between treatment groups.
Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors
Jan 2008A significant number of brain tumor patients who received radiation or chemotherapy have thinking problems as a result of their treatment. The purpose of this study is to find out if treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients with brain tumors who received radiation or chemotherapy. This research will also study whether persons having particular genes for a blood-borne substance called apolipoprotein E (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment for their brain tumors. The findings of this study will help us find out whether Aricept can improve thinking abilities after cancer treatment, and whether some of the thinking difficulties may be in part related to having certain genes.
Risk Factors for Adult-Onset Brain Tumors
Jan 2008This is a case-control investigation. Persons affected with a brain tumor are compared to unaffected persons on previous medical history, diet and other factors. Those enrolled in the study will participate in an interview on general background, diet, medical history and lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water sample from your home. All procedures are performed in the clinic or through the mail.
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia or High-Risk Myelodysplastic Syndrome
Jan 2008This phase II trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation and donor bone marrow transplant and to see how well they work in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
Coping in African American Prostate Cancer Survivors (CAAPS)
Dec 2007This study will test the effectiveness of an 8-week group intervention for African American men who have been treated for prostate cancer.
Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men
Dec 2007This study is being done to see if a standard tool used to check anxiety in white men works well for Black men.
Early Onset and Familial Gastric Cancer Registry
Dec 2007The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers.
A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer
Dec 2007The purpose of the research is to determine if blood tests and a CT scan done before surgery can predict how successful the surgery will be. In patients who have cancer of the ovary that has spread, it is hoped that the CT scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure.
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Dec 2007The main goal of the study is to find out if adding lovastatin to paclitaxel increases the number of people whose tumors shrink or whose disease responds to the treatment.
Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21
Dec 2007The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.
Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
Dec 2007The purpose of the study is to see if we will be more able to tell what the risk is for bladder cancer to reoccur or worsen when genetics and risk factors are examined along with the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type of cancer tends to come back after being treated and is often more aggressive when it returns. We already know, that the "stage" or how deeply the tumor grows into the bladder wall and the "grade" or how fast the tumor grows affect whether the tumor will come back or get worse over time. Now we use information about the stage and grade of your tumor to decide how to treat the tumor and how often you should be checked after the treatment is over. However, this has not been very reliable, because each person has unique genetic characteristics and other factors that are likely to affect what happens to the tumor over time. For instance, we know the risk for developing a cancer may be affected by your surroundings and other factors such as what you eat, the type of habits you have such as smoking, and the type of job you have, but not everyone exposed to the same risk factors gets a cancer. We believe this is due to unique genetic characteristics in each person which may help their body fight cancer.
Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Dec 2007This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.
Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
Dec 2007Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
A Combination of Imatinib Mesylate and Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia (UMCC 2006-128)
Dec 2007A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations: A Combination of Imatinib Mesylate & Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia.
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine combined with Protocolized Surgery in Resectable Gastric Cancer
Dec 2007Assessment of the feasibility and toxicity of the combination of 4 courses of docetaxel/Taxotere, cisplatin and capecitabine/Xeloda as neoadjuvant chemotherapy in resectable localized or locally advanced gastric cancer
New therapeutic approaches in the treatment of anaplastic thyroid cancer: a phase II trial of valproic acid and paclitaxel in solid tumours
Dec 2007Evaluation of the antitumour activity of valproic acid and paclitaxel in patients with anaplastic thyroid cancer
High-dose sequential chemotherapy and rituximab (R-HDS) in HIV+ patients with non-hodgkin lymphoma (NHL) refractory or relapsed after 1st line treatment
Dec 2007To assess incidence of infectious complications and mortality after R-HDS in HIV+ patients
Vaccine Study for Surgically Resected Pancreatic Cancer
Dec 2007To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with chemotherapy and chemoradiation.
Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
Dec 2007This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer.
Nov 2007To compare Overall Survival (OS) of patients administered Larotaxel in combination with cisplatin for the treatment of locally advanced/metastatic urothelial tract or bladder cancer
Open-label, efficacy and safety study of bevacizumab (Avastin) in combination with XELOX (Oxaliplatin plus Xeloda) for the first-line treatment of patients with locally advanced or metastatic cancer of the colon or rectum -"OBELIX"
Nov 2007To confirm the efficacy of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) based regimen, based on progression free survival
SHORT-HER: Multicentric randomised phase III trial of adjuvant chemotherapy plus 3 vs 12 months of trastuzumab in breast cancer patients with HER2 positive disease
Nov 2007Primary objective is to evaluate if 3 months (9 weekly administrations) of Herceptin (H) administered according to the Finnish protocol are not inferior to 12 months (18 three-weekly administrations) in a standard chemotherapy protocol in term of disease free survival, in patients with HER2 positive early breast cancer.
A Randomized, Double-Blind, Parallel, Three Arm, Multicenter, Phase II Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination with Taxol®/Paraplatin® (Paclitaxel/Carboplatin) Compared to Taxol®/Paraplatin® Alone in Previously Untreated Subjects with Lung Cancer
Nov 2007To compare the immune-related progression free survival (irPFS) of subjects receiving ipilimumab in combination with concurrent Taxol®/Paraplatin® (“concurrent”; Arm A) to that of subjects receiving Taxol®/Paraplatin® alone (Arm C) in Stage IIIb/IV NSCLC subjects using irRC as per the assessment of an independent review committee (IRC).
Neoadjuvant chemotherapy followed by surgical debulking and intraperitoneal chemohyperthermia for stage III ovarian cancer. A prospective phase II study
Nov 2007The main aim of this phase II prospective study is the evaluation of the effectiveness of neoadjuvant chemotherapy followed by surgical debulking and intraperitoneal chemohyperthermia in patients with stage III primary ovarian cancer.
TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma
Nov 2007The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.
COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophago-gastric adenocarcinoma
Nov 2007To assess whether chemotherapy with docetaxel improves survival in patients with advanced gastric cancer previously treated with platinum/fluoropyrimidine or raltitrexed therapy.
Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Nov 2007The purpose of the investigators' study is to prospectively evaluate whether nucleoid antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).
A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women with Newly Diagnosed, Previously Untreated, Gynaecological Tumors
Oct 2007The primary objective of this study is to verify the safety and tolerability of treatment with daily pazopanib added to two regimens of paclitaxel and carboplatin in women with previously untreated, advanced gynaecological tumors: Paclitaxel 175 mg/m2 and Carboplatin AUC 5 given every 3 weeks for up to 6 cycles (Arm A), and Paclitaxel 175 mg/m2 and Carboplatin AUC 6 given every 3 weeks for up to 6 cycles (Arm B).
A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women with Newly Diagnosed, Previously Untreated, Gynaecological Tumors
Oct 2007The primary objective of this study is to verify the safety and tolerability of treatment with daily pazopanib added to two regimens of paclitaxel and carboplatin in women with previously untreated, advanced gynaecological tumors: Paclitaxel 175 mg/m2 and Carboplatin AUC 5 given every 3 weeks for up to 6 cycles (Arm A), and Paclitaxel 175 mg/m2 and Carboplatin AUC 6 given every 3 weeks for up to 6 cycles (Arm B)
A phase II, randomized, multi-center study, assessing value of adding RAD 001 to Trastuzumab as preoperative therapy of HER-2 positive primary breast cancer amenable to surgery
Oct 2007To evaluate the added efficacy obtained by the association of Trastuzumab with RAD001 as preoperative therapy of primary HER-2 positive breast cancer as shown by increased clinical tumor response rate.
Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
Oct 2007To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.
A Multicenter, Open-Label, Randomized Study Comparing the Efficacy and Safety of S-1 as a Single Agent at 30 mg/m2 BID versus 5-FU Bolus Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer Previously Treated with a Gemcitabine Based-Regimen
Oct 2007To determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy
Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START Protocols: Long Term Safety and Efficacy Analysis.
Oct 2007The primary objective is to determine the long term safety and tolerability of dasatinib. The secondary objective of this study is to collect long term efficacy in terms of molecular response.
Pharmacokinetic Perspective Study In Colorectal Cancer Patients And Candidate For Fluoropyrimidine Therapy: 5-Fluoro Test
Oct 2007To evaluate 5-FU e 5-FDHU pharmacokinetic parameters after a test-dose administration (5-FU 250 mg/mq ev. bolus). To analyse possible correlations between pharmacokinetic results and adjuvant or first line treatment tolerability in colorectal cancer patients. To exclude from fluoropyrimidine therapy patients with significant alterations of 5-FU and 5-FDHU pharmacokinetics (CL<1 l/h/mq, T1/2β>5 h, and Cmax<0.1 µg/ml, Tmax>60 min, respectively) after the administration of the 5-FU test-dose.
Phase II study of neoadjuvant chemoradio therapy in locally advanced rectal cancer
Sep 2007Efficacy evaluation in terms of pathological complete response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer
Pancreatic Cancer Genetic Epidemiology (PACGENE) Study
Sep 2007Our study is part of a multicenter, multidisciplinary Pancreatic Cancer Genetic Epidemiology (PACGENE) consortium to identify susceptibility genes in high risk FPC pedigrees using cutting-edge genetic analysis methods.
Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function
Sep 2007The purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history.
Phase ll study evaluating the toxicity and efficacy of a modified German Paediatric Hodgkin's Lymphoma protocol (HD95) in young adults (aged 18-30 years) with Hodgkin's Lymphoma
Sep 2007Main objective of this study is to determine whether young adults (18-30 years) can receive modified HD95 therapy without experiencing excessive neurotoxicity due to the intensive use of Vinca alkaloids in this regimen.
Sexual Functioning in Cervical Cancer Survivors
Aug 2007Primary Objectives: 1. To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 2. To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 3. To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and 4. To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.
Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.
Aug 2007Evaluer l'efficacité du Lanréotide LP dans la diminution de la lymphorrhée entre H0 et H0 + 96h après curage axillaire.
A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular disease
Aug 2007The primary objective is to assess the efficacy of IPH1101 associated with low dose of IL-2 as add-on therapy to imatinib in CML patients with residual molecular disease after at least 2 years of imatinib monotherapy.
A randomized, multicentral, phase III study of parallel groups to compare the efficiency and tolerance of Fulvestrant (Faslodex) administered for three years in combination with Anastrozol (Arimidex) for 5 years versus Anastrozol for 5 years as adjuvant hormonotherapy in postmenopausal women with early breast cancer and positive hormonal receptors.
Aug 2007To compare free disease survival of patients treated with Fulvestrant for 3 years and anastrozol for 5 years vesus free disease survival of patients treated with anastrozol for 5 years.
A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.
Aug 2007The main objectives of this study are: to assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and to assess in a randomized comparison the effect of bevacizumab on the CR rate.
DNA Array Analysis of Patients With Cervical Cancer
Aug 2007The primary objectives of this study are: To obtain preliminary descriptive data on early changes in tumor DNA array expression following chemo-radiation of cervical cancer. These data will permit the design a future studies to correlate array expression changes with clinical outcome. To quantify the degree of therapy-induced apoptosis following chemo-radiation of cervical cancer in order to design future studies to correlate apoptosis levels with clinical outcome. To store material to later correlate the tumor DNA array expression with specific strains of tumor-related human papilloma virus (HPV) and finally to correlate changes in biomarker expression with clinical outcome and findings of the DNA array analyses.
A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after firrst-line chemotherapy in patients with HER1 and/or HER2 over expressing locally advanced or metastatic bladder cancer.
Aug 2007The main objective of the study is to compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV bladder cancer who have been randomised to maintenance therapy with lapatinib or placebo following first-line chemotherapy
A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
Jul 2007This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer.
Effect of mechanical bowel preparation with polyethylene glycol plus bowel enema (glycerin 5%) vs bowel enema alone in patients candidates to colorectal resection for malignancy. Prospective randomized clinical trial.
Jul 2007The main objective is to determine the incidence of post operative complications.
A multicenter, open-label, randomized, phase II/III study to evaluate the safety and efficacy of combretastatin a-4 phosphate in combination with paclitaxel and carboplatin in comparison with paclitaxel and carboplatin against anaplastic thyroid carcinoma
Jul 2007To compare the antineoplastic efficacy of combretastatin A-4 phosphate + paclitaxel + carboplatin+ with paclitaxel + carboplatin against anaplastic thyroid carcinoma by measuring overall survival
Simple Versus Radical Hysterectomy for Stage I Cervical Cancer
Jul 2007The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
Jul 2007Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg
Topical Imiquimod in Treating Patients With Recurrent Paget's Disease of the Vulva
Jul 2007This clinical trial is studying how well topical imiquimod works in treating patients with recurrent Paget's disease of the vulva.
A phase II study to evaluate the efficacy of bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.
Jul 2007To evaluate the overall survival after 1 year of treatment with bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.
Open, uncontrolled, non-commercial Clinical Trial of induction chemotherapy with Cetuximab, Docetaxel, Cisplatin, 5FU followed by Cetuximab + radiotherapy in the responders in locally advanced resectable SCCHN
Jul 2007To assess the efficacy of induction chemotherapy with Cetuximab+Docetaxel+Cisplatin +5-FU followed by Cetuximab + radiotherapy in the responders in SCCHN patients. Rate of complete clinical response (imaging and physical examination) will be assessed at 3 months after the end of treatment.
Outpatients high-dose chemotherapy supported by autologus peripheral blood stem and single-dose pegfilgrastim in patients with lymphoproliferative malignances.
Jul 2007evaluation of mortality due to febrile neutropenia; evaluation of incidence of febrile neutropenia; percentage of readmissions to the hospital due to febrile neutropenia
Applicability of TachoSil® in sealing rectal anastomoses. A feasibility trial.
Jul 2007The primary objective is to establish a procedure for the application of TachoSil® following establishment of rectal anastomoses. For this purpose a number of no more than15 patients will be included who will all have TachoSil® applied to their rectal anastomoses. If data from less than 15 patients are sufficient to establish a procedure for application of TachoSil® the trial will be stopped before 15 patients are included for evaluation.
A randomized phase III study comparing trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant treatments for early breast cancer
Jun 2007The aim of this study is to compare to compare trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant treatments for early breast cancer
Randomized Phase III Trial to evaluate the effect of statins on tumour biology in non-small cell lung cancer.
Jun 2007The primary objective is to evaluate and compare changes in tumour cell proliferation measured through tumour Ki-67 expression following treatment with pravastatin or lovastatin.
Bevacizumab+folfiri in untreated patients with advanced colorectal cancer. A phase II multicenter study of the Gruppo Oncologico dell'Italia Meridionale. (GOIM).
Jun 2007The main objectives are to determine the objectively confirmed response rate and time-to- progression.
Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)
Jun 2007The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.
A Phase IIIb, Randomized, Active Controlled Open Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
Jun 2007The main study is designed to demonstrate that sunitinib at a starting daily dose of 37.5 mg orally (with a continuous daily regimen) can significantly improve PFS compared with imatinib at a dose of 800 mg in patients whose disease has progressed during treatment with imatinib at a dose of 400 mg.
Data Collection for Patients With Low Grade Ovarian Carcinoma
Jun 20071.To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1000 female patients with low-grade ovarian and peritoneal tumors. These include ovarian tumors of low malignant potential, low-grade serous ovarian carcinoma, primary peritoneal tumors of low malignant potential, low-grade carcinomas of the peritoneum, and psammocarcinoma. 2.To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome. 3.To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.
Pharmacokinetical-clinical study of intravescical gemcitabine in patients with marker lesion of superficial transitional cell carcinoma of the bladder
Jun 2007The aim of this study is to define the optimal values of the next parameters for the intravescical administration of gemcitabine 20000 mg: pH of the instilled solution: pH 2.7-3.2 (unbuffered solution) or pH 5.5 (buffered solution) dwell time: 1 hour or 2 houres concentration of gemcitabine (20 mg/ml or 40 mg/ml)
An open–label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients with Persistent or Progressive Disease after, or Relapse within One Year of, Completion of Standard First Line Therapy
Jun 2007To determine a safe dose of rIL-21 in combination with PLD, and to assess the efficacy of this combination in terms of overall response rate (RR).
A Phase I/II, Ascending, Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients with Metastatic or Locally Advanced Solid Malignancies.
Jun 2007To assess the safety and tolerability of BMS-663513 in the range of 0.3 mg/kg to 15 mg/kg administered once every 3 weeks to patients with metastatic or locally advanced solid malignancies in the dose escalation portion of the study. To estimate the reversible Grade 3-4 toxicity rate in the expanded dose cohorts of melanoma, ovarian and renal carcinoma patients at each of the 3 selected doses (1, 3 and 10 mg/kg).
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Jun 2007The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
An open label phase II study to evaluate the efficacy and safety of induction and consolidation therapy with dasatinib in combination with chemotherapy in patients aged 55 years and over with philadelphia chromosome positive (PH+ or BCR-ABL+) acute lymphoblastic leukemia (ALL).
Jun 2007To evaluate the efficacy of a dasatinib-based induction and consolidation therapy