Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: platinum resistant ovarian cancer recurrent ovarian cancer platinum resistant cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

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 cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.

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 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.

Arms:
arm 1: 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.

Interventions: intervention 1: Topotecan intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV. intervention 2: bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Protocol document: