Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 111
- Locations
- 3
- Primary Endpoint
- Recurrence rate of transitional cell carcinoma (TCC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fenretinide
Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
Intervention: Fenretinide (Drug)
Placebo
Placebo orally every day for 12 months, taken 25 out of every 28 days.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Recurrence rate of transitional cell carcinoma (TCC)
Time Frame: 1 year
Recurrence rates is defined as proportion of participants who recur within one year of surgery.
Secondary Outcomes
No secondary outcomes reported