Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.
|Prostate Cancer||Drug: carboplatin Drug: docetaxel Drug: estramustine phosphate sodium||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer|
|Study Start Date:||March 1999|
|Study Completion Date:||April 2003|
- Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer.
- Determine the safety and efficacy of this regimen in this patient population.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-5 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 5 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005627
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||William Oh, MD||Dana-Farber Cancer Institute|