Phase II Trial Of Sequential Estramustine/Paclitaxel Followed By Doxorubicin/Ketoconazole In Patients With Androgen-Independent Prostate Cancer
OBJECTIVES: I. Determine the safety, efficacy, and durability of docetaxel and estramustine
followed by doxorubicin and ketoconazole in patients with high-risk, androgen-independent
prostate cancer. II. Determine whether anticoagulation with warfarin can reduce the
frequency of thromboembolic complications associated with estramustine in these patients.
OUTLINE: Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and
docetaxel IV over 1 hour on day 3 weekly. Patients also receive oral warfarin daily.
Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease
progression or unacceptable toxicity. Regimen B: After completion of regimen A, patients
receive doxorubicin IV over 30 minutes weekly and oral ketoconazole twice daily. Treatment
repeats every 4 weeks for a total of 2 courses in the absence of disease progression or
unacceptable toxicity. Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
William K. Kelly, DO
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|