Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer|
|Study Start Date:||May 2000|
- 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.