Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer
- Registration Number
- NCT00002914
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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 piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Nashville
🇺🇸Nashville, Tennessee, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
🇺🇸Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States