Combination Chemotherapy in Treating Patients With Bladder Cancer
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder Any T, N+, M0 OR T3a-4a, N0, M0 At least 6 weeks but no more than 3 months since prior complete resection of bladder Cystoprostatectomy plus pelvic lymph node dissection in males Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females Negative surgical margins Carcinoma in situ allowed No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Hematopoietic: Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 150,000/mm^3 Hepatic: Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST ≤ 2 times ULN Renal: Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 60 mL/min Cardiovascular: Normal cardiac function by history, physical exam, or chest radiograph Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease No New York Heart Association class III or IV heart disease No serious cardiac arrhythmias including first-, second-, and third-degree heart block Other: Negative pregnancy test No uncontrolled infection No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to bladder
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Arroyo Grande Community Hospital
- Rebecca and John Moores UCSD Cancer Center
- Kaiser Permanente Medical Office -Vandever Medical Office
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Front Range Cancer Specialists
- Poudre Valley Hospital
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- St. Francis Hospital
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Lynn Regional Cancer Center of Boca Raton Community Hospital
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Memorial Cancer Institute at Memorial Regional Hospital
- Mayo Clinic - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Watson Clinic
- CCOP - Mount Sinai Medical Center
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Emory University Hospital - Atlanta
- Hematology and Oncology of Northeast Georgia
- MBCCOP-Medical College of Georgia Cancer Center
- John B. Amos Community Cancer Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Eureka Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology Hematology Associates, Limited - West
- Provena St. Mary's Wasser Regional Cancer Center - Kankakee
- Kewanee Hospital
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers
- Elkhart General Hospital
- Indiana University Cancer Center
- William N. Wishard Memorial Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Saint Joseph Regional Medical Center - Plymouth Campus
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- McFarland Clinic, P.C.
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Cancer Center at Mercy Medical Center
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Wendt Regional Cancer Center at Finley Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Siouxland Regional Cancer Center
- Siouxland Hematology-Oncology Associates
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A.
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas - Winfield
- Central Maine Medical Center
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Center at Union Hospital
- Lawrence Memorial Hospital of Medford
- CCOP - Michigan Cancer Research Consortium
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- William Beaumont Hospital - Royal Oak Campus
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Mercy and Unity Hospitals
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Veterans Affairs Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Cancer Care Center at Regions Hospital
- Saint Francis Cancer Center
- St. Joseph's Hospital
- Park Nicollet Clinic
- United Hospital
- Ridgeview Medical Center
- Woodwinds Hospital
- Missouri Cancer Associates
- CCOP - Kansas City
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- St. Anthony's Cancer Center
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Great Falls Clinic
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- University Medical Center of Southern Nevada
- CCOP - Southern Nevada Cancer Research Foundation
- Cancer Institute of New Jersey at the Cooper University Hospital
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey at Hamilton
- Fox Chase Virtua Health Cancer Program - Marlton
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Roswell Park Cancer Institute
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Lipson Cancer and Blood Center at Rochester General Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Long Island Cancer Center at Stony Brook University Hospital
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Veterans Affairs Medical Center - Syracuse
- Community General Hospital of Greater Syracuse
- Randolph Hospital
- Batte Cancer Center at Northeast Medical Center
- Duke Comprehensive Cancer Center
- John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Lenoir Memorial Cancer Center
- Annie Penn Cancer Center
- Rutherford Hospital
- Wilson Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Bismarck Cancer Center
- Medcenter One Health System
- Mid Dakota Clinic, P.C.
- St. Alexius Medical Center
- Akron City Hospital at Summa Health System
- St. Elizabeth Boardman Cancer Center
- Adena Regional Medical Center
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Community Oncology Group - Independence
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center Oncology Unit
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- St. Joseph Health Care Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
- Genesis - Good Samaritan Hospital
- Oklahoma University Medical Center
- Legacy Mount Hood Medical Center
- Cancer Treatment Center at Merle West Medical Center
- Providence Milwaukie Hospital
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Legacy Meridian Park Hospital
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Central Pennsylvania Hematology and Medical Oncology Associates, PC
- Lewistown Hospital
- Riddle Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Pottstown Memorial Regional Cancer Center
- Geisinger Medical Group
- Mount Nittany Medical Center
- Geisinger Wyoming Valley Medical Center
- Rhode Island Hospital
- Miriam Hospital at Lifespan
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- Roper St. Francis Healthcare - Roper Hospital
- Bon Secours St. Francis Health System
- Greenville Hospital System Cancer Center
- CCOP - Greenville
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- CCOP - Upstate Carolina
- Sioux Valley Hospital and University of South Dakota Medical Center
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- Danville Regional Medical Center
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- Cancer Center at Southwest Washington Medical Center
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- St. Mary's Medical Center
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Fox Valley Hematology and Oncology
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- UW Health Oncology
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Medical College of Wisconsin Cancer Center
- University of Wisconsin Cancer Center at Aspirus Wausau Hospital
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Gemcitabine + cisplatin
Gemcitabine + Doxorubicin + Pegfilgrastim