NCT00005820

Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	nitrocamptothecin

Timeline

• Start date: 2000-05-01
• Primary completion: 2004-09-01
• Completion: 2006-09-01
• First posted: 2004-04-12
• Last updated: 2016-07-13

Locations

50 sites across 1 country: United States