Fallopian Tube
A Phase III, Multicenter, Randomized, Blinded, Placebo-Controlled Trail of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum-Sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
Eligibility Criteria (per Protocol dated 10/15/08):
- Histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred more than 6 months after platinum-based chemotherapy.
- No prior chemotherapy in the recurrent setting.
- Measurable disease according to modified RECIST with at least on lesion that can be accurately measured in at least one dimension (longest dimension recorded).
- Greater than 28 days from and recovered from prior radiation therapy or surgery.
- ECOG Performance status of 0 or 1.
- Not eligible if there has been prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma.
- Not eligible if there is a history of abdominal fistula, GIP, or intra-abdominal abscess.
- Not eligible if there are clinical symptoms of GI obstruction or requirements of parenteral hydration, parenteral nutrition, or tube feeding.
- Not eligible if there is evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
- Other criteria, as determined by the protocol.