Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study|
- Maximum tolerated dose of docetaxel [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2003|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix.
- Determine the response rate and time to progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.
- Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I.
Quality of life is assessed at baseline, before every other course of treatment, and at the end of study treatment.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084890
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1065|
|Study Chair:||Brigitte E. Miller, MD||Comprehensive Cancer Center of Wake Forest University|