Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
- Determine the response rate in patients with platinum-sensitive or -resistant relapsed
or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine
- Determine the toxicity of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to treatment failure and progression-free survival of patients
treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
treatment with a platinum-containing regimen (platinum-resistant disease vs
Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1
and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR
(≥ 6 total courses of treatment).
PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant
disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
From date of registration to date of death from any cause
Robert T. Morris, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Oakwood Cancer Center at Oakwood Hospital and Medical Center||Dearborn, Michigan 48123-2500|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Sinai-Grace Hospital||Detroit, Michigan 48235|