Prostate Cancer Clinical Trial
Official title:
Phase II Trial Of Sequential Estramustine/Paclitaxel Followed By Doxorubicin/Ketoconazole In Patients With Androgen-Independent Prostate Cancer
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.
Anticoagulant drugs such as warfarin may reduce the risk of blood clots.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus warfarin
in treating patients who have 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
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