S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy Any T, N0-3, M1 or unresectable M0 Poorly differentiated TCC, predominant TCC with rare foci of squamous differentiation, or rare foci of adenocarcinoma allowed Measurable disease At least 1 lesion accessible for biopsy Soft tissue disease that has been irradiated within the past 2 months not considered measurable disease Progressive or recurrent disease after only 1 prior systemic chemotherapy regimen for advanced disease No adenocarcinoma, small cell carcinoma, sarcoma, squamous cell carcinoma, or mixed histology PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,200/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: See Disease Characteristics No prior adjuvant chemotherapy At least 28 days since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 28 days since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 28 days since prior surgery and recovered Other: No prior systemic therapy between biopsy and study entry At least 28 days since prior intravesical therapy and recovered No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, or St. John's Wort)
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- MBCCOP - Gulf Coast
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- Cancer Center and Beckman Research Institute, City of Hope
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Veterans Affairs Medical Center - West Los Angeles
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Medical Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Cancer Center
- Veterans Affairs Medical Center - Denver
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- MBCCOP - University of Illinois at Chicago
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- Providence Hospital - Southfield
- CCOP - Duluth
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Herbert Irving Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Barrett Cancer Center, The University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- CCOP - Toledo Community Hospital Oncology Program
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Oregon Cancer Center
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- CCOP - Greenville
- CCOP - Upstate Carolina
- Veterans Affairs Medical Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Baylor College of Medicine
- Texas Tech University Health Science Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Eastern Virginia Medical School
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
- Madigan Army Medical Center
Arms of the Study
Arm 1
Experimental
ZD 1839