A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer
- Determine the objective response rate (complete response, partial response, and stable
disease for ≥ 16 weeks) in patients with persistent, recurrent, or refractory advanced
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with
- Determine the time to disease progression, median survival time, and duration of
overall CA-125 antigen response in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
reaction to prior platinum-based regimen (sensitive vs insensitive).
Patients receive oral AZD2171 once daily for 4 weeks. Courses repeat every 4 weeks for up to
8 months in the absence of disease progression or toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate (complete and partial response and stable disease) for ≥ 16 weeks as assessed by RECIST criteria
Hal W. Hirte, MD, FRCP(C)
Margaret and Charles Juravinski Cancer Centre
United States: Food and Drug Administration
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|