Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborators: Genentech, Inc.; GlaxoSmithKline
• Treatments: Bevacizumab; Topotecan

Criteria

Inclusion Criteria:

• must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen

• must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line)

• must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart

• performance status greater than or equal to 70%

Exclusion Criteria:

• prior treatment with anti-angiogenesis agent

• treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)

• evidence of other malignancy within 3 years of study enrollment

• history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation

• history of intra-abdominal abscess with 6 months prior to day 0

• pregnant or lactating patients