Spots Global Cancer Trial Database for Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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