Tipifarnib in Treating Patients With Recurrent Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00047216|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: tipifarnib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||March 2006|
- 1-year recurrence-free survival
- Recurrence rate at 3, 6, 9, and 12 months
- Progression rate at 3, 6, 9, and 12 months
- Survival rate
- Time to treatment failure
- Molecular changes in the host tissue
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047216
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|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|