Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Phase 3 Completed 111 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab

RandomizedSingle-groupTriple-blindTreatment

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.

Timeline

Start: 1998-07-30
Primary completion: 2005-03-01
Completion: 2005-03-01

Outcome

Missed primary endpoint

paper The 1-year recurrence rates by Kaplan-Meier estimate were 32.3% (placebo) versus 31.5% (fenretinide; P = 0.88 log-rank test). PMID 18172274 ↗

paper Although well tolerated, fenretinide did not reduce the time-to-recurrence in patients with Ta, T1, or Tis TCC of the bladder. PMID 18172274 ↗

Publications

Results Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fenretinide	Small molecule	200 mg	Oral