Status:
COMPLETED
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
GlaxoSmithKline
Genentech, Inc.
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 c...
Detailed Description
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemother...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00343044
Start Date
June 1 2006
End Date
August 1 2011
Last Update
May 15 2015
Active Locations (2)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
2
Puget Sound Oncology Consortium (PSOC)
Seattle, Washington, United States, 98104