Status:
COMPLETED
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00434642
Start Date
April 1 2007
End Date
July 1 2013
Last Update
August 9 2017
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