Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.
Peritoneal Cavity Cancer
Drug: Gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer|
- Overall survival [ Time Frame: From date of registration to date of death from any cause ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Every two cycles ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Docetaxel & Gemcitabine hydrochloride
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Other Name: Taxotere®Drug: Gemcitabine hydrochloride
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Other Name: Gemzar ®
- Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.
- 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 platinum-sensitive disease).
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 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227721
|United States, Michigan|
|Oakwood Cancer Center at Oakwood Hospital and Medical Center|
|Dearborn, Michigan, United States, 48123-2500|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Virginia|
|Northern Virginia Pelvic Surgery Assoc|
|Annandale, Virginia, United States, 22003|
|Principal Investigator:||Robert T. Morris, MD||Barbara Ann Karmanos Cancer Institute|