Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer|
- Maximum Tolerated Dose [ Time Frame: Up to 180 Days ] [ Designated as safety issue: Yes ]Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
- Response to Treatment [ Time Frame: Up to 180 Days ] [ Designated as safety issue: Yes ]Determine the response rate in patients treated with this drug.
- Pharmacokinetics [ Time Frame: Day 1 through Day 5 ] [ Designated as safety issue: No ]Determine the pharmacokinetics associated with this drug in these patients.
|Study Start Date:||March 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Metronomic Docetaxel
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
Three patients will be enrolled and dosed at each level; from dose level 1 of 2.9 mg/m^2/day up to dose level 6 of 6.4 mg/m^2/day
Other Name: Taxotere
- Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer.
- Determine the response rate in patients treated with this drug.
- Determine the pharmacokinetics associated with this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel intravenously (IV) over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity.
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.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287885
|Study Chair:||Levi S. Downs, MD||Masonic Cancer Center, University of Minnesota|