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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab; Carboplatin; Gemcitabine

Criteria

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)