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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00077402
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.
Secondary
* Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
* Determine the duration of PSA response in patients treated with this drug.
* Determine PSA progression-free survival of patients treated with this drug.
* Determine overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each course, and at the end of therapy.
PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.
Study:
NCT00077402
Study Brief:
Protocol Section:
NCT00077402