Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
- Registration Number
- NCT00004154
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo orally every day for 12 months, taken 25 out of every 28 days. Fenretinide Fenretinide Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
- Primary Outcome Measures
Name Time Method Recurrence rate of transitional cell carcinoma (TCC) 1 year Recurrence rates is defined as proportion of participants who recur within one year of surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States