Ovarian Cancer Clinical Trial
Official title:
Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent 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.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of metronomic docetaxel in patients with
progressive or recurrent gynecologic cancer.
Secondary
- 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.
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