Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase II trial is studying bevacizumab to see how well it works when given with or without everolimus in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|
- Progression-free survival hazard ratio [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by CTCAE v4.0 [ Designated as safety issue: Yes ]
- Comparison of progression-free and overall survival of patients with measurable disease vs those with detectable (non-measurable) disease [ Designated as safety issue: No ]
- Frequency of objective tumor response in patients with measurable disease [ Designated as safety issue: No ]
- Frequency of CA-125 response [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral everolimus once daily on days 1-28.
Given IVDrug: everolimus
Experimental: Arm II
Patients receive bevacizumab as in arm I and oral placebo once daily on days 1-28.
Given IVOther: placebo
- To compare the progression-free survival hazard ratio in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with bevacizumab with vs without everolimus.
- To determine the nature and degree of toxicity of these regimens.
- To compare the progression-free and overall survival of patients with measurable disease vs those with detectable (non-measurable) disease.
- To estimate the proportion of patients with measurable disease who have objective tumor response to treatment.
- To provide descriptive information about CA-125 response by regimen and, where possible, by objective tumor response.
OUTLINE: This is a multicenter study. Patients are stratified according to their platinum-free interval (≤ 182 days vs > 182 days), measurable disease status (measurable vs non-measurable or "detectable" disease), and prior treatment with bevacizumab/aflibercept (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral everolimus once daily on days 1-28.
- Arm II: Patients receive bevacizumab as in arm I and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
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|Study Chair:||William P. Tew, MD||Memorial Sloan-Kettering Cancer Center|