Clinical Trials
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Women's Health and Obs/Gyn
Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery
Apr 2013The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
Bone Healing in Healthy and Post-menopausal Osteoporotic Women
Mar 2013Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 15 post-menopausal osteoporotic women and 15 healthy pre or post menopausal women by the use of cone-beam computer tomography (CBCT) images. As secondary outcome the investigators put: changes in the external contour of the ridge together with periodontal parameters in the neighbouring teeth, tissue blood perfusion changes during the initial healing (assessed by laser doppler flowmetry) and levels of serum bone resorption/formation markers.
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.
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).
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
Mar 2013The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.
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
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
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.
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.
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients (ESCALE)
Feb 2013The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
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.
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)
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.
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.
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.
Acid-suppressing Drugs Pregnancy Asthma Offspring Study
Feb 2013The purpose of this study is - To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood. - To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.
RCT: Added Value of Coordinator for the Management of Hip Fracture Patients
Feb 2013To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.
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.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old. This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.
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
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.
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.
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.
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.
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.
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.
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Nov 2012The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months.
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Nov 2012This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.
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.
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.
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.
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.
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.
VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
Oct 2012The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
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.
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.
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.
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.
An Extension Study to Evaluate Six Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
Sep 2012• Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo.
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.
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.
Observational Study of Prolia® in Postmenopausal Women With Osteoporosis
Aug 2012The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting
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.
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).
Safety and Efficacy of tablets containing extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo in the treatment of the cystitis with Ciproxin
Aug 2012To observe the safety of tablets containing an extract of Hibiscus Sabdariffa (HS) and Propoli versus placebo as co adjuvant for the treatment of cystitis in patients > o =18 years
Teriparatide and Risedronate in the Treatment of Patients with Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Jul 2012The primary objective of this study is to evaluate if teriparatide 20 μg subcutaneously once daily is superior in reducing the incidence of new vertebral fractures during 24 months of therapy, when compared with risedronate 35 mg orally once weekly, in postmenopausal women with prevalent vertebral fragility fractures.
Cabazitaxel in platinum refractory ovarian cancer. A phase II trial
Jul 2012To investigate the response rate of cabazitaxel in platinum refractory, ovarian cancer.
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
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 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
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
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.
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
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)
Study of a National Cohort of Adult Patients With Phenylketonuria (ECOPHEN)
Jun 2012Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)
May 2012This is an Open-label, prospective, randomized, multi-center post-market study.
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 Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012For the overall study period (12-month double-blind alendronate [ALN]-controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO
Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
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.
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
May 2012To assess the noninferiority of ceftazidime-avibactam compared with doripenem with respect to symptomatic resolution of UTI-specific symptoms and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment
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.
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.
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
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Apr 2012The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
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
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
Apr 2012To assess the noninferiority of ceftazidime-avibactam (CAZ-AVI, formerly CAZ104) compared with doripenem with respect to the following coprimary endpoints in the microbiological modified intent-to-treat (mMITT) analysis set: •Symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) and resolution of, or improvement in, flank pain based on the patient-reported symptom assessment response at the Day 5 visit •Both per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the Test of Cure (TOC) visit
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort (ARTEOS2)
Apr 2012The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.
Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life
Apr 2012The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients with Complicated Urinary Tract Infection
Apr 2012To evaluate the efficacy of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg) with respect to the microbiological response assessment profile in the treatment of adult patients with cUTI, as compared to imipenem/cilastatin at completion of IV study therapy (DCIV).
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 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.
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
Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial
Apr 2012The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable
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 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.
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Apr 2012The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. The primary objective in the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.
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.
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.
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.
Determination of the penetration of antibiotics into epithelial lining fluid during continuous infusion in mechanically ventilated ICU patients: example meropenem
Mar 2012Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients
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
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients with Complicated Urinary Tract Infection
Mar 2012To evaluate the efficacy of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg) with respect to the microbiological response assessment profile in the treatment of adult patients with cUTI, as compared to imipenem/cilastatin at completion of IV study therapy (DCIV). To evaluate the safety and tolerability profile of 2 doses of MK-7655 + imipenem/cilastatin (250 mg and 125 mg).
A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis
Mar 2012To assess the effect of AMG 785 treatment for 12 months compared with placebo on the subject incidence of new vertebral fracture
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.
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).
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of female subjects with Bladder Pain Syndrome / Interstitial Cystitis
Feb 2012To investigate efficacy of ASP3652 in female subjects with BPS/IC
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.
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
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
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)
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)
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 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.
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (BILANZ)
Jan 2012The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
Jan 2012The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation. The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
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 Blinded Extension to 5 Years of a Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Dec 20111) To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. 2) To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo.
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.
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.
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.
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.
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Nov 2011Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: - the data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL during late pregnancy and infants - Its efficacy in the reduction of HBV vertical transmission rate
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?
Multicentre, randomized, open-label, two-arm parallel groups, active controlled study design to demonstrate efficacy and tolerability of clodronate 200 mg/4 ml solution for intramuscular use with 1% lidocaine every other week vs clodronate 100 mg/3,3ml solution for intramuscular use with 1% lidocaine once-week in a 1-year treatment period of women with postmenopausal osteoporosis
Nov 2011To demonstrate that disodium clodronate 200 mg/4 ml solution for i.m. use with 1% lidocaine administered every other week is not-inferior to disodium clodronate 100 mg/3,3 ml for i.m. use with 1% lidocaine administered once-week in terms of lumbar Bone Mineral Density (BMD).
Prospective Multicentre Randomized Double-Blind Placebo-Controlled Parallel Group Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Symptomatic Bacterial Urinary Tract Infections
Nov 2011To demonstrate the clinical efficacy and tolerability of the inactivated germs of specified enterobacteria contained in StroVac® in recurrent acute uncomplicated symptomatic bacterial urinary tract infections as compared to placebo.
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?
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.
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.
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.
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.
Comparison of the effect of an ongoing treatment with alendronate or a drug holiday on the fracture risk in osteoporotic patients with a bisphosphonate long term therapy
Sep 2011Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Chloroquine for Malaria in Pregnancy
Sep 2011The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each time) to the standard practice of preventive treatment intervals in pregnancy (with the drug sulfadoxine-pyrimethamine given twice during pregnancy).
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.
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 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with oral bisphosphonates
Aug 2011To demonstrate the effect of strontium ranelate versus placebo of treatment on the areal bone mineral density (BMD) of the lumbar spine in postmenopausal women with osteoporosis previously treated with oral bisphosphonates.
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.
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)
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.
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.
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.
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.
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).
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
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.
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.
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
Influence of an Asthma Education Programme on Asthma Control During Pregnancy
Apr 2011Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.
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.
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.
A multicenter, double-blind, randomized, phase 3 study to compare the safety and efficacy of intravenous CXA 201 and intravenous Levofloxacin in complicated Urinary Tract Infection, including Pyelonephritis
Feb 2011To demonstrate the non-inferiority of CXA-201 versus comparator (levofloxacin) in adult subjects with cUTI (including pyelonephritis) based on the difference in composite microbiological eradication and clinical cure rate in the mMITT population at the test-of-cure (TOC) visit (7 days [± 2 days] after last treatment) (CXA-201 minus comparator [levofloxacin]), using a non inferiority margin of 10%.
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.
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.
A Randomized, Double-blind, Placebo-controlled, Comparative Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of BA058 for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis and at Risk of Fracture
Jan 2011Determine the comparative safety and efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo.
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Jan 2011The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.
A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forsteo in Postmenopausal Women with Osteoporosis
Jan 2011To characterize percent change from baseline in bone mineral density (BMD) at L1-L4 axial lumbar spine after 24 weeks of once daily treatment of 5 mg tablets of rhPTH(1 31)NH2.
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.
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
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).
Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
Dec 2010This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).
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).
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.
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.
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
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.
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
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.
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.
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)
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
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)
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.
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care.
Aug 20101. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT? 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover?
Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
Aug 2010The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune response (body's defense against foreign substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding mothers receiving the flu vaccine shot. Healthy post-partum women (240 volunteers, 28-120 days post delivery) who plan to breastfeed through 28 days post vaccination and who have not received 2010-2011 influenza vaccine will be assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray. Study procedures include: nasal swabs, blood samples, and completion of memory aids. Participants will be involved in this United States based study for about 6 months.
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.
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)
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.
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.
A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to reduce the Risk of Fracture in Osteoporotic Men Treated with Vitamin D and Calcium
Jun 2010(1) To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months; (2)To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.
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)
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.
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.
Topical Imiquimod in Treating Patients with Persistent HPV-Infection after Surgical or Radiation Treatment of Cervical Cancer
Apr 2010HPV-clearance 20 weeks after randomization.
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.
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Apr 2010To assess the effects of strontium ranelate in the management of aseptic fractures of the lower limbs with delayed union or non-union.
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.
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.
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women.
Mar 2010To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices
Efficacy of Metformin in Pregnant Obese Women, a Randomised Controlled Trial.
Mar 2010The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies.
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.
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.
Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy (IPTp_IST)
Mar 2010The goal of this project is to determine whether in pregnant women who sleep under a long lasting insecticide treated bed net, screening and treatment at each scheduled antenatal clinic visit is as effective in protecting them from anaemia, low birth weight and placental infection as SP-IPTp.
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.
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.
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.
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.
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
Nov 2009To assess the efficacy of S6911 after 3 months of treatment
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Women (PROMOTE-PIs)
Oct 2009This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria.
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.
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.
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.
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
Aug 2009The purpose of this study is •to determine the rate of osteoporosis among patients with advanced prostate cancer. •to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis
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.
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 Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates.
Jul 2009To evaluate the change in total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous daily or weekly bisphosphonate therapy to denosumab 60 mg SC Q6M compared to that in subjects transitioning to ibandronate 150mg PO QM.
Community Based Obesity Prevention Among Black Women
Jul 2009This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.
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.
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.
Jun 2009The primary objective of the study is to evaluate the effect of denosumab 60 mg every 6 months (Q6M) compared with Actonel® 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous alendronate therapy.
Ixabepilone to Treat Cervical Cancer
Jun 2009Objective is to determine whether ixabepilone is effective for treating cervical 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.
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.
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.
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.
Study of the Molecular Genetics of Menstrual Migraine
May 2009The aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.
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.
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).
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 Substudy to Explore Biomarkers of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium
Mar 2009To evaluate the phenotypic distribution of aLBM, SPPB, and gait speed in the study population. Specifically to determine if, at baseline, measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution. To identify biomarkers of sarcopenia by evaluating low aLBM, low SPPB, and low gait speed, separately and in combination, by examining DNA and RNA in circulating blood.
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
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.
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.
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.
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.
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.
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.
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Dec 2008People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
A Phase III, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0826/Ertapenem and Meropenem in Patients with Complicated Urinary Tract Infections
Nov 20081) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious (requiring hospitalization and treatment with parenteral therapy) complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at the 5 to 9 days posttherapy (EFU/TOC) follow-up visit. 2) To compare the efficacy of ertapenem with respect to the clinical response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at completion of parenteral therapy (DCIV). 3) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at DCIV. 4) To evaluate the safety profile of ertapenem at DCIV.
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Nov 2008The purpose of this study is to rigorously test the incremental impact of simple, generalizable interventions to improve healthcare among older women at high risk for osteoporosis
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.
Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom
Oct 2008Demonstrate efficacy and safety of temocillin in urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae.
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.
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.
An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Sep 2008In postmenopausal women with osteoporosis: To estimate the effect of treatment with MK-0822 50 mg once weekly (OW) on volumetric trabecular bone mineral density (vBMD) at the lumbar spine (assessed by QCT) at Month 12, Month 24, and end of study.
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.
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.
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
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.
An randomized, controlled, investigator-blinded, prospective, mono-centre study to evaluate the efficacy of fosfomycin versus meropenem in patients with complicated urinary tract infections
Jul 2008This study will primarily address the question of the efficacy of intravenous fosfomycin 4 g b.i.d. in the therapy of patients presenting with complicated urinary tract infection. These data will be compared to meropenem administered intravenously at a dose of 2 g b.i.d.
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.
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.
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.
The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women
Apr 2008To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.
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 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.
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.
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.
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.
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
Sep 2007To demonstrate the efficacy over 1 year of strontium ranelate compared to placebo on lumbar BMD in men with osteoporosis.
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.
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 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.
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 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.
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.
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 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
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.
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).
Influence of urinary acidification by l-Methionine on bone metabolism and acid base status
Jun 2007To assess the impact of l-methionine intake on bone metabolism.
Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence
Jun 2007The main objectives of the trial are to determine if the GP2 + GM-CSF vaccine reduces the recurrence rate in HLA-A2+, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone. Also to determine if the AE37 + GM-CSF vaccine reduces the recurrence rate in HLA-A2-, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone.
ANZAC: A Randomised Phase II Feasibility Study Investigating The Biological Effects of the Addition of Zoledronic Acid To Neoadjuvant Comnination Chemotherapy On Invasive Breast Cancer
May 2007The principle objective is to study the short-term biological effects of treatment and whether the addition of zoledronic acid to combination neoadjuvant (pre-operative) chemotherapy causes additive or synergistic efects on tumour growth ininvasive breast cancer; specifically assessing apoptosis (programmed cancer cell death) and proliferation (cancer activity). It is hoped the study will determine whether the addition of zoledronic acid to neoadjuvant chemotherapy causes an increase in apoptosis between the diagnostic core biopsy and an additional core biopsy for research purposes on day 5, compared to neoadjuvant chemotherapy alone.
Pharmacogenetic study of FcγRIIIa and HER2 genes in relation to treatment of breast cancer
Apr 2007Primary objectives are: to determine the influence and frequency of polymorphisms in the FcγRIIIa, HER2 and other related genes on response to trastuzumab with respect to time-to-progression (TTP) and outcome (in patients with advanced/ metastatic breast cancer). To determine the frequency of polymorphisms in the HER2 gene and their association with HER2 expression in tumour samples in both the adjuvant and metastatic setting.
HPV Testing for Cervical Cancer Screening Study
Apr 2007This is a randomised controlled trial of HPV testing with cytology triage for HPV positive women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has recommended its use and as it is likely to be the standard of care by the time these data are published, the trial has been designed to account for this. Further, LBC will improve the cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as well as cytology and thereby allows the triage testing to be undertaken from the same sample without having to recall the women.
NGR012 A phase II study of NGR-hTNF administered in combination with doxorubicin every 3 weeks in patients affected by advanced or metastatic ovarian cancer
Apr 2007Antitumor activity defined as response rate according to RECIST criteria
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
Apr 2007This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.
A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy
Mar 2007In each of the two study arms (lapatinib plus topotecan or lapatinib plus capecitabine), the primary objective is to determine the CNS objective response rates in subjects with progressive brain metastases from ErbB2-overexpressing breast cancer. A CNS objective response is defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of brain magnetic resonance imaging (MRI), provided there is no progression of systemic disease outside of the CNS or increasing steroid requirements.
Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
Mar 2007This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.
A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Feb 2007To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with alendronate on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for 1 year.
Fludeoxyglucose F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
Dec 2006This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer.
Carboplatin Gemcitabine as second line treatment in platinum sensitive advanced ovarian cancer phase II study on a new schedule.
Nov 2006The primary objective of this study is to evaluate the myelotoxicity in patients treated with carboplatin plus gemcitabine according to a new schedule in which carboplatin is administered on day 2 of the cycle. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy at least 6 months after treatment discontinuation.
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
Nov 2006To evaluate progression-free survival (PFS) of the combination regimen versus each of the monotherapy arms in subjects with FIGO Stage IVB, or recurrent or persistent cervical cancer who have had zero or one prior chemotherapy regimen for advanced disease
Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures (AVOID Fracture)
Oct 2006The intent of this research is to improve quality of care for patients at high risk of fracture, by increasing rates of testing and treatment of osteoporosis.
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD)
Sep 2006Main objective: To assess the safety, tolerability, and biochemical efficacy (changes in urinary NTx) of MK-0822 in women with breast cancer and MBD. Secondary objectives: To assess the efficacy of MK-0822 on additional biochemical parameters and its pharmakokinetic properties
Phase II study of definitive radiochemotherapy for locally advanced squamous cell cancer of the vulva: an efficacy study
Sep 2006The primary objective is to gain experience with primary radiochemotherapy and to determine the locoregional response rate at 12 weeks after radiochemotherapy and after groin dissection for cN1,2 patients.
Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Jul 2006The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic and treatment strategies for women 50 years and over who have suffered a fragility fracture.
A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
Jul 2006This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.
Elizabeth Registry for Low Grade Ovarian Cancer
Jun 2006Long-Term Objectives: •To establish an ongoing national research registry of epidemiologic, clinical and pathologic data on low grade and low malignant potential (LMP) ovarian cancer patients in UTMDACC's Department of Gynecologic Oncology for research purposes. •To create a bank of low grade and LMP ovarian cancer tumor blocks for study of the molecular and histopathologic differences among low grade ovarian cancer, ovarian LMP tumors and high grade ovarian cancer. •To specify the epidemiologic and clinical profile of low grade and LMP ovarian cancer patients. •To identify potential precursors of low grade and LMP ovarian cancer. •To assess treatment patterns to guide management of these diseases. •To collect quality of life and health outcomes data on these patients. •To achieve a fundamental understanding of low grade and LMP ovarian cancer that will inform prevention and screening efforts, motivate development of improved treatments and eventually result in a cure. The short-term objectives are: •To detail procedures for potential registrant identification and recruitment. •To create a demographic and health history questionnaire for potential registrants. •To begin aggregating low grade and low malignant potential ovarian tumor blocks. •To specify a timeline for the development of all other aspects of the Registry.
Phase II study with capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer
Jun 2006To evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Jun 2006This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer.
May 2006To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression in subjects with advanced breast cancer and bone metastases.
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
Apr 2006The 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.
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.
Apr 2006The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva.
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.
Apr 2006The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women & Infants Hospital
Study of Polymorphisms in Predicting the Effects of Curative External-Beam Radiotherapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer
Mar 2006This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.
Phase 3 randomized study of TLK286 (Telcyta™) in combination with liposomal doxorubicin (Doxil®/Caelyx®) versus liposomal doxorubicin (Doxil®/Caelyx®) as second-line therapy in platinum refractory or resistant ovarian cancer
Feb 2006To demonstrate superiority in the objective response rate of TLK286 in combination with liposomal doxorubicin as compared to active control therapy with liposomal doxorubicin.
Phase II clinical and pharmacokinetic study of pegylated liposomal doxorubicin and gemcitabine in advanced ovarian carcinoma
Jan 2006To assess : - time to progression and treatment response rate
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