S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
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 anterior urethral cancer, localized transitional cell cancer of the renal pelvis and ureter, posterior urethral cancer, stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer, regional transitional cell cancer of the renal pelvis and ureter
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed The following diagnoses are not allowed: Small cell carcinoma Sarcomatoid components Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present Residual disease after second TURBT allowed No more than 14-56 days after second TURBT No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic White blood cell count (WBC) at least 3,500/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least lower limit of normal Hepatic Bilirubin no greater than 1.5 mg/dL Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal Renal Creatinine no greater than 2.0 mg/dL AND/OR Creatinine clearance at least 60 mL/min Other No prohibitive medical risk that would preclude radical cystectomy No other serious concurrent systemic disorder that would preclude study compliance No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Prior intravesical immunotherapy allowed Chemotherapy No prior systemic chemotherapy for TCC of the urothelium Prior intravesical chemotherapy allowed Endocrine therapy Not specified Radiotherapy No prior radiotherapy for TCC of the urothelium No concurrent radiotherapy Surgery See Disease Characteristics
Sites / Locations
- Cancer Center at Providence Alaska Medical Center
- Banner Thunderbird Medical Center
- Banner Desert Medical Center
- Banner Baywood Medical Center
- Banner Good Samaritan Medical Center
- CCOP - Western Regional, Arizona
- Providence Saint Joseph Medical Center - Burbank
- USC/Norris Comprehensive Cancer Center and Hospital
- University of California Davis Cancer Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- Shaw Cancer Center at Vail Valley Medical Center
- North Colorado Medical Center
- McKee Medical Center
- Montrose Memorial Hospital Cancer Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Decatur Memorial Hospital Cancer Care Institute
- Good Samaritan Regional Health Center
- Regional Cancer Center at Memorial Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Christus Schumpert Cancer Treatment Center
- Cancer Research Center at Boston Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metropolitan Hospital
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Holland Community Hospital
- Foote Hospital
- Sparrow Regional Cancer Center
- Hackley Hospital
- Seton Cancer Institute - Saginaw
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - St. Louis-Cape Girardeau
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Big Sky Oncology
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Adirondack Cancer Care - Glens Falls
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- Forsyth Regional Cancer Center at Forsyth Medical Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Legacy Meridian Park Hospital
- AnMed Health Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- University of Tennessee Cancer Institute - Medical Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Latter Day Saints Hospital
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Gemcitabine, Paclitaxel, Carboplatin
Gemcitabine, Paclitaxel, Carboplatin followed by surgery