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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00343044

Run by

Benaroya Research Institute

People needed

40

Starts

2006-06-01

Expected to finish

2011-08-01

Last updated by the study team

2015-05-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States
• Puget Sound Oncology Consortium (PSOC) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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