RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.
OBJECTIVES: * Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic, hormone refractory prostate cancer. * Determine time to disease progression and duration of response in this patient population as a result of this treatment regimen. * Determine the safety, tolerance, and toxicity of this treatment regimen in these patients. OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until evidence of progression or relapse for a maximum of 2 years from the date of registration. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
median time to disease and PSA progression
Time frame: Up to 2 years
overall survival
Time frame: Up to 2 years
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