Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
- Conditions
- Prostate Cancer
- Interventions
- Drug: nitrocamptothecin
- Registration Number
- NCT00005820
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nitrocamptothecin nitrocamptothecin 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.
- Primary Outcome Measures
Name Time Method median time to disease and PSA progression Up to 2 years
- Secondary Outcome Measures
Name Time Method overall survival Up to 2 years
Trial Locations
- Locations (50)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Scroll for more (40 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States