PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM
OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the
survival of patients with advanced urothelial carcinoma previously treated with systemic
cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients.
OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks
followed by 1 week of rest. Patients with responding or stable disease continue treatment
every 4 weeks until unacceptable toxicity or progression intervenes.
PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1
response is observed in the first 14 evaluable patients.
Interventional
Primary Purpose: Treatment
Bruce J. Roth, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
CDR0000065289
NCT00002914
May 1997
March 2004
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |