Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00077402
- Lead Sponsor
- Cancer Therapeutics Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate as measured by RECIST at ≥ 9 weeks
- Secondary Outcome Measures
Name Time Method Toxicity as measured by NCI CTC
Trial Locations
- Locations (6)
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Sir Charles Gairdner Hospital - Perth
🇦🇺Perth, Western Australia, Australia
Johns Hopkins Singapore International Medical Centre
🇸🇬Singapore, Singapore
National Cancer Centre - Singapore
🇸🇬Singapore, Singapore
Cancer Institute at National University Hospital
🇸🇬Singapore, Singapore
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong