Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer|
- Response rate as measured by RECIST at ≥ 9 weeks [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]
|Study Start Date:||November 2003|
|Study Completion Date:||February 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077402
|Australia, New South Wales|
|Sydney Cancer Centre at Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital - Perth|
|Perth, Western Australia, Australia, 6009|
|Prince of Wales Hospital|
|Shatin, New Territories, Hong Kong|
|Cancer Institute at National University Hospital|
|Singapore, Singapore, 119074|
|Johns Hopkins Singapore International Medical Centre|
|Singapore, Singapore, 308433|
|National Cancer Centre - Singapore|
|Singapore, Singapore, 169610|
|Study Chair:||Michael Boyer||Sydney Cancer Centre at Royal Prince Alfred Hospital|