Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT00005820
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.
Study:
NCT00005820
Study Brief:
Protocol Section:
NCT00005820