Bladder Cancer Clinical Trial
Official title:
Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial 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.
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.
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