Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Up to 180 Days
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration