Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
Peritoneal Cavity Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma|
- Toxicity [ Designated as safety issue: Yes ]
- Response rates (complete and partial response) [ Designated as safety issue: No ]
- Relapse rates [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
- Determine the response rates (complete and partial response) in patients treated with this regimen.
- Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217568
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Pacific Gynecology Specialists|
|Seattle, Washington, United States, 98104|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Leona A. Holmberg, MD, PhD||Fred Hutchinson Cancer Research Center|