PHASE I/II STUDY OF DOCETAXEL (TAXOTERE) AND ESTRAMUSTINE COMBINATION CHEMOTHERAPY IN PATIENTS WITH PROSTATE CANCER
OBJECTIVES: I. Determine the maximum tolerated dose, toxicity, and pharmacokinetic profile
of docetaxel in combination with estramustine in patients with metastatic adenocarcinoma of
the prostate. II. Determine the safe dose level of this regimen for Phase II evaluation.
III. Determine the efficacy of this regimen with evaluation of objective response rate,
duration of response, and time to disease progression in these patients. IV. Determine the
duration of survival of these patients on this regimen. V. Evaluate the symptomatic and
quality of life effects in these patients.
OUTLINE: This is a dose escalation study (phase I). Patients are stratified into one of two
risk groups by number of prior chemotherapy regimens (0-2 vs greater than 2) and occurrence
and site(s) of prior radiation. Patients receive oral estramustine three times daily
beginning 24 hours prior to docetaxel and continuing for 4 days after infusion. Patients
receive docetaxel IV over 1 hour every 21 days. Cohorts of 3-6 patients receive escalating
doses of docetaxel until the maximum tolerated dose (MTD) is reached (phase I). The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity. A minimum of 6 patients receive treatment at the MTD. Phase II: Patients receive
docetaxel IV at the MTD from phase I. Treatment continues in the absence of disease
progression or unacceptable toxicity for both phases. Quality of life is assessed. Patients
are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 13-19
months.
Interventional
Primary Purpose: Treatment
Daniel P. Petrylak, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000064755
NCT00002775
February 1998
Name | Location |
---|---|
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |