Trials / Completed
CompletedNCT00287885
Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Cervical Cancer
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- Sarcoma
- Vaginal Cancer
- Vulvar Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | docetaxel | 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 |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2006-02-07
- Last updated
- 2017-11-29
Source: ClinicalTrials.gov record NCT00287885. Inclusion in this directory is not an endorsement.