A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
- Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA)
response rate, in patients with advanced or metastatic hormone-refractory prostate
- 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.
Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST at ≥ 9 weeks
Sydney Cancer Centre at Royal Prince Alfred Hospital
United States: Federal Government