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A Phase III Study of Carboplatin and Paclitaxel Alone or with Bevacizumab Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
[Protocol 08-074]
- Full Title :
- A PHASE III RANDOMIZED, CONTROLLED, CLINICAL TRIAL OF CARBOPLATIN AND PACLITAXEL ALONE OR IN COMBINATION WITH BEVACIZUMAB (NSC#708465, IND# 7921) FOLLOWED BY BEVACIZUMAB AND SECONDARY CYTOREDUCTIVE SURGERY IN PLATINUM-SENSITIVE, RECURRENT OVARIAN, PERITONEAL PRIMARY AND FALLOPIAN TUBE CANCER. NCI-SUPPLIED AGENTS: BEVACIZUMAB (NSC# 704865, IND# 7921)(GOG 213)
- Purpose :
The standard way to treat recurrent ovarian, primary peritoneal, and fallopian tube cancer is to do a second surgery to remove any visible cancer. Patients then receive the anticancer drug carboplatin and paclitaxel. Treatment with chemotherapy can work, but a long-term cure is not common. In many patients, the cancer will grow back and will need to be treated again.
The purpose of this study is to see if the time until the cancer recurs can be lengthened. Doctors will first decide if a woman is a candidate for surgery. Even though most women have had the surgery in the past, doctors do not really know if it helps them. Women who are surgical candidates will be randomly assigned to receive surgery or no surgery. After that portion of the study is completed, these women will be randomly assigned to receive carboplatin and paclitaxel with or without bevacizumab, a drug used to treat advanced colon, lung, and breast cancers that is being investigated for the treatment of other cancers.
Women who are not surgical candidates will participate in the chemotherapy part of the study. They, too, will be randomly assigned to receive carboplatin and paclitaxel either with or without bevacizumab. Researchers will compare time to tumor recurrence, overall survival, and quality of life between the various groups.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of recurrent ovarian, primary peritoneal, or fallopian tube cancer.
- Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles) and a treatment-free interval without clinical evidence of progressive disease lasting at least 6 months.
- Patients who have received pelvic radiation therapy and those who have received more than one prior regimen of chemotherapy may not participate.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Mario Leitao at 212-639-3987.
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