A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer
OBJECTIVES:
- 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.
Interventional
Primary Purpose: Treatment
William Oh, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000067775
NCT00005627
March 1999
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |