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| Sponsor: | Princess Margaret Hospital, Canada |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00047216 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: tipifarnib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder |
| Study Start Date: | November 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the bladder with or without associated carcinoma in situ
Complete transurethral resection of bladder tumor performed within past 4 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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 | |
| Canada, Ontario | |
| Sunnybrook and Women's College Health Sciences Centre | |
| North York, Ontario, Canada, M4N 3M5 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| St. Joseph's Hospital | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Study Chair: | Joseph Chin, MD | London Regional Cancer Program at London Health Sciences Centre |
More Information
| Study ID Numbers: | CDR0000257564, PMH-PHL-007, NCI-5612 |
| Study First Received: | October 3, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00047216 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent bladder cancer stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
|
Neoplasms by Histologic Type Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Neoplasms, Glandular and Epithelial Tipifarnib |