A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer
OBJECTIVES:
Primary
- 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
AZD2171.
Secondary
- 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.
Interventional
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
No
Hal W. Hirte, MD, FRCP(C)
Study Chair
Margaret and Charles Juravinski Cancer Centre
United States: Food and Drug Administration
CDR0000456204
NCT00278343
March 2006
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |