AZD2171 in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
Recruitment status was Active, not recruiting
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Drug: cediranib maleate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer|
- Objective tumor response rate (complete and partial response and stable disease) for ≥ 16 weeks as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Progression-free and overall survival at the median time-point and 6 months [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Duration of overall CA-125 antigen response [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Notre-Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|Study Chair:||Hal W. Hirte, MD, FRCP(C)||Margaret and Charles Juravinski Cancer Centre|