Tipifarnib in Treating Patients With Recurrent Bladder Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder|
- 1-year recurrence-free survival [ Designated as safety issue: No ]
- Recurrence rate at 3, 6, 9, and 12 months [ Designated as safety issue: No ]
- Progression rate at 3, 6, 9, and 12 months [ Designated as safety issue: No ]
- Survival rate [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Molecular changes in the host tissue [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
- Determine the 1-year recurrence-free survival rate of patients with stage 0 or I recurrent transitional cell carcinoma of the bladder treated with tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047216
|United States, Illinois|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 355|
|St. Joseph's Hospital|
|Hamilton, Ontario, Canada, L8N 4A6|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Sunnybrook and Women's College Health Sciences Centre|
|North York, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Joseph Chin, MD||London Health Sciences Centre|