Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor.
PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer|
- Recurrence rate of transitional cell carcinoma (TCC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Recurrence rates is defined as proportion of participants who recur within one year of surgery.
|Study Start Date:||June 2000|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
Other Name: 4-HPR
Placebo Comparator: Placebo
Placebo orally every day for 12 months, taken 25 out of every 28 days.
- Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
- Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.
Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.
Patients are followed every 3 months for 15 months.
PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Washington|
|Veterans Affairs Medical Center - Seattle|
|Seattle, Washington, United States, 98108|
|Study Chair:||Anita L. Sabichi, MD||M.D. Anderson Cancer Center|