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

Benaroya Research Institute

Status and phase: Completed; Phase 2

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Topotecan; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00343044

3040200

AVF3648s (Other Identifier)

Details and patient eligibility

About

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.

Full 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 chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment

Experimental group

Description:

Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.

Treatment:

Drug: Bevacizumab

Drug: Topotecan