R115777 in Treating Patients With Advanced Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have advanced bladder cancer.
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter||Drug: chemotherapy Drug: tipifarnib||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of R115777, an Oral Farnesyltransferase Inhibitor (FTI) in Previously Untreated Patients With Advanced Urothelial Tract Transitional Cell Carcinoma|
|Study Start Date:||March 2000|
|Study Completion Date:||May 2005|
OBJECTIVES: I. Determine the efficacy of R115777 in terms of objective response in patients with advanced transitional cell cancer of the urothelial tract. II. Determine the safety of this treatment regimen in these patients. III. Determine the time to disease progression in these patients with this treatment regimen.
OUTLINE: This is a multicenter study. Patients receive oral R115777 every 12 hours for 21 days in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for at least 2 courses. Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006376
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||John Seigne, MB||H. Lee Moffitt Cancer Center and Research Institute|