A Phase III Randomized, Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC# 704865, IND#7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum- Sensitive Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer: GOG-0213
Standard of care treatment for recurrent ovarian, fallopian tube, or peritoneal primary cancer usually consists of 2 chemotherapy drugs, given every 3 weeks for a total of 6 treatments. This study is comparing the combination of Carboplatin, Paclitaxel, and Bevacizumab to the standard combination of Carboplatin and Paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life.
A second purpose of this study is to determine if a secondary surgery to remove a tumor, followed by chemotherapy can increase the time that participants remain disease free. After surgery you will be randomized to 1 of the 2 chemotherapy regimens.
Another purpose of this study is to test samples for participant's blood, tumor tissue (from previous surgery) and both tumor and normal tissue taken during the surgery associated with the study.
The time participants can expect to spend in this study is determined by which study regimen the participant is assigned to.
Participants and/or their insurance provider are responsible for some or all of the costs associated with treating their cancer.
In general, this study is looking for participants who:
- Age 18 years or older.
- Have NEGATIVE serum pregnancy test, with an acceptable form of contraception in use.
- Have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent.
- Have complete response to front- line platinum- taxane (at least 3 cycles)
- Have recurrence documented by elevated CA-125 or measurable disease
Janet L. Osborne, M.D.
Carilion GYN Oncology Associates