NCT00866723

Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

Phase II Study of Single-Agent Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous, Papillary Serous Endometrial or Fallopian Tube Cancer Who Have Recurred After Prior Therapy With Maintenance Avastin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how the participant's disease (ovarian, primary peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to additional treatment with Avastin (bevacizumab). Participants have already received Avastin as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy that is given to people to prevent a relapse. However, cancer may return after maintenance therapy. This research study hopes to determine whether additional treatment with Avastin will be effective in treating the participant's cancer.

Detailed description

OBJECTIVES: Primary: To determine the activity of bevacizumab in patients with epithelial ovarian, primary peritoneal serous, papillary serous endometrial or fallopian tube cancer who relapse after achieving an initial complete response to first-line therapy that included at least 6 month bevacizumab maintenance as defined by: 1) clinical response rate OR 2) clinical benefit response Secondary: * To assess duration of progression free survival (PFS) * To assess the safety * To correlate response with the Avastin-free interval STATISTICAL DESIGN: This study used a two-stage design to evaluate efficacy of bevacizumab based on a patient achieving either clinical response or clinical benefit response. The null and alternative response rates were 10% and 30%. If two or more patients enrolled in the stage one cohort (n=10 patients) achieved response than accrual would proceed to stage two (n=19 patients). If response was achieved by at least 6 patients in the final set of 29 evaluable patients then bevacizumab would be deemed worthy for further study. This design had 80% power given one-sided 0.05 significance level.

Conditions

• Ovarian Cancer
• Primary Peritoneal Serous Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2009-03-20
• Last updated: 2018-05-22
• Results posted: 2014-11-25

Locations

3 sites across 1 country: United States