A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate 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.

Inclusion Criteria:

• Signed Informed Consent Form
• Age ≥ 18 years
• Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
• No prior chemotherapy in the recurrent setting
• Measurable disease
• Recovered from prior radiation therapy or surgery

Exclusion Criteria:

• Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
• History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
• Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
• Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
• Current, recent, or planned participation in an experimental drug study
• History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
• Inadequately controlled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association Class II or greater congestive heart failure (CHF)
• History of myocardial infarction or unstable angina
• History of stroke or transient ischemic attack (TIA)
• Known central nervous system (CNS) disease except for treated brain metastasis
• Significant vascular disease or recent peripheral arterial thrombosis
• History of hemoptysis
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)