A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
Summary
This is a placebo-controlled, randomized, multicenter Phase III study evaluating the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Ovarian Cancer
Intervention
bevacizumab, carboplatin, gemcitabine, placebo
Status
Active, not recruiting
Source
Genentech
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00434642
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Topotecan
An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
Ovarian Failure, Premature
Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.
Primary Ovarian Insufficiency
Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.
Carboplatin
An organoplatinum compound that possesses antineoplastic activity.
Ovarian Hyperstimulation Syndrome
A complication of OVULATION INDUCTION in infertility treatment. It is graded by the severity of symptoms which include OVARY enlargement, multiple OVARIAN FOLLICLES; OVARIAN CYSTS; ASCITES; and generalized EDEMA. The full-blown syndrome may lead to RENAL FAILURE, respiratory distress, and even DEATH. Increased capillary permeability is caused by the vasoactive substances, such as VASCULAR ENDOTHELIAL GROWTH FACTORS, secreted by the overly-stimulated OVARIES.
Clinical Trials
Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients
The goal of this clinical research study is to learn if bevacizumab, when given in combination with gemcitabine, docetaxel, melphalan and carboplatin, or with topotecan, cyclophosphamide a...
The purpose of this study is to determine the MTD/recommended Phase II dose of E7080 administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and...
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
- this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an a...
Bevacizumab and Carboplatin for Patients With Ovarian Cancer
This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.
Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer
The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have a...
PubMed Articles
PURPOSE: To evaluate the pharmacokinetics of bevacizumab following IP and IV administration, and to investigate combined bevacizumab therapy (IP or IV) with IP paclitaxel or carboplatin in a mouse mod...
BACKGROUND: The potential of gemcitabine to interact with carboplatin was explored in a phase II trial in 'platinum-resistant' ovarian cancer. Peripheral blood lymphocytes (PBLs) were sampled after dr...
PURPOSE Although gemcitabine and carboplatin (GCa) is a standard option for patients with advanced urothelial cancer (UC) who are ineligible for cisplatin, outcomes remain poor. This trial evaluated t...
PURPOSE Gemcitabine plus cisplatin is active in malignant mesothelioma (MM), although single-arm phase II trials have reported variable outcomes. Vascular endothelial growth factor (VEGF) inhibitors h...
