S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium
Bladder Cancer, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage III bladder cancer, squamous cell carcinoma of the bladder, stage II bladder cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, distal urethral cancer, proximal urethral cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary or recurrent invasive carcinoma of the urothelium Transitional, squamous, or mixed cell subtypes allowed Primary disease site must be the urinary bladder or urethra Disease confined to the true pelvis (T2-T4, N0-N3, M0) Must meet at least 1 of the following criteria: Nodal involvement at or below the level of the bifurcation of the iliac vessels Medically or surgically inoperable Patient refused cystectomy Measurable or nonmeasurable disease Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days No extrapelvic metastases Eligible to receive radiotherapy Planned radiotherapy at a SWOG-approved facility PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least lower limit of normal Hepatic Bilirubin no greater than upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal Creatinine clearance at least 60 mL/min OR Creatinine no greater than ULN Gastrointestinal No chronic diarrhea No malabsorption No extensive diverticular disease of the colon No inflammatory bowel disease No other pre-existing gastrointestinal disorders Other Not pregnant or nursing Fertile patients must use effective contraception No active infections requiring antibiotics No other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago No prior carboplatin No prior paclitaxel No prior gemcitabine Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior pelvic radiotherapy Surgery See Disease Characteristics Recovered from prior surgery
Sites / Locations
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center at UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- University of California Davis Cancer Center
- CCOP - Santa Rosa Memorial Hospital
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- MBCCOP - Howard University Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- CCOP - Atlanta Regional
- MBCCOP - Hawaii
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago Westside Hospital
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center at Tulane University Hospital and Clinic
- Veterans Affairs Medical Center - New Orleans
- Veterans Affairs Medical Center - Shreveport
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Cancer Research Center at Boston Medical Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Health System
- CCOP - Grand Rapids
- CCOP - Beaumont
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- CCOP - Kansas City
- Saint Louis University Cancer 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
- Western New York Urology Associates
- NYU Cancer Institute at New York University Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- CCOP - Southeast Cancer Control Consortium
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- CCOP - Columbia River Oncology Program
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee Cancer Institute at Methodist Central Hospital
- Harrington Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Veterans Affairs Medical Center - Amarillo
- Brooke Army Medical Center
- University of Texas Medical Branch
- M.D. Anderson Cancer Center at University of Texas
- Baylor College of Medicine
- UMC Southwest Cancer and Research 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 at University of Utah
- Veterans Affairs Medical Center - Salt Lake City
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest