Combination Chemotherapy in Treating Patients With Bladder Cancer

NCT00014534 | Completed Phase 3 DMC

• 5 other identifiers: CALGB-90104P30CA008748MSKCC-00138NCI-G01-1935CDR0000068554
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 285

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.

Conditions

Bladder Cancer

Keywords

stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• Overall survival

  4 years

Study Arms (2)

Gemcitabine + cisplatin

ACTIVE COMPARATOR

Drug: cisplatin; Drug: gemcitabine hydrochloride

Gemcitabine + Doxorubicin + Pegfilgrastim

ACTIVE COMPARATOR

Biological: filgrastim; Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride

Interventions

filgrastim BIOLOGICAL

6 mg sub Q

Gemcitabine + Doxorubicin + Pegfilgrastim

cisplatin DRUG

60 mg/sq m IV

Gemcitabine + cisplatin

doxorubicin hydrochloride DRUG

50 mg/ sq m IV

Gemcitabine + Doxorubicin + Pegfilgrastim

gemcitabine hydrochloride DRUG

1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm

Gemcitabine + Doxorubicin + Pegfilgrastim; Gemcitabine + cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (285)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Arroyo Grande Community Hospital

Arroyo Grande, California, 93420, United States

Location

Rebecca and John Moores UCSD Cancer Center

San Diego, California, 92103, United States

Location

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80524, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80502, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thorton, Colorado, 80229, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Lynn Regional Cancer Center of Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224-9980, United States

Location

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Albany, Georgia, 31703, United States

Location

Emory University Hospital - Atlanta

Altanta, Georgia, 30322, United States

Location

Hematology and Oncology of Northeast Georgia

Athens, Georgia, 30607, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

John B. Amos Community Cancer Center

Columbus, Georgia, 31902, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Provena St. Mary's Wasser Regional Cancer Center - Kankakee

Kankakee, Illinois, 60901, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

William N. Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Saint Joseph Regional Medical Center - Plymouth Campus

Plymouth, Indiana, 46544, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Genesis Medical Center - West Campus

Davenport, Iowa, 52804, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Wendt Regional Cancer Center at Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101-1733, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, P.A. - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, P.A. - Parsons

Parsons, Kansas, 67357, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A.

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-8936, United States

Location

Union Hospital Cancer Center at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Lawrence Memorial Hospital of Medford

Medford, Massachusetts, 02155, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48100, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Mercy and Unity Hospitals

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Litchfield, Minnesota, 55355, United States

Location

St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

Cancer Care Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Cancer Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Woodwinds Hospital

Woodbury, Minnesota, 55125, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

St. Anthony's Cancer Center

St Louis, Missouri, 63128, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Deaconess Billings Clinic Cancer Center

Billings, Montana, 59107, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Eastern Montana Cancer Center

Miles City, Montana, 59301, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59802, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, 08053, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Lipson Cancer and Blood Center at Rochester General Hospital

Rochester, New York, 14621, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13057, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Community General Hospital of Greater Syracuse

Syracuse, New York, 13215, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203, United States

Location

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital

Eden, North Carolina, 27288, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27401, United States

Location

Lenoir Memorial Cancer Center

Kinston, North Carolina, 28501, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Akron City Hospital at Summa Health System

Akron, Ohio, 44304, United States

Location

St. Elizabeth Boardman Cancer Center

Boardman, Ohio, 44512, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 54601, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Oncology Group - Independence

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center Oncology Unit

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

St. Joseph Health Care Center

Warren, Ohio, 44484, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown

Youngstown, Ohio, 44510, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Mount Hood Medical Center

Glesham, Oregon, 97030, United States

Location

Cancer Treatment Center at Merle West Medical Center

Klamath Falls, Oregon, 97601, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Institute of Oncology at Vilnius University

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Central Pennsylvania Hematology and Medical Oncology Associates, PC

Lemoyne, Pennsylvania, 17043, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Riddle Memorial Hospital

Media, Pennsylvania, 19063, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Pottstown Memorial Regional Cancer Center

Pottstown, Pennsylvania, 19464, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital at Lifespan

Providence, Rhode Island, 02906, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Healthcare - Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29304, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

Cancer Center at Southwest Washington Medical Center

Vancouver, Washington, 98668, United States

Location

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, 25304, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Fox Valley Hematology and Oncology

Appleton, Wisconsin, 54911-3496, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

UW Health Oncology

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

University of Wisconsin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Filgrastim; Cisplatin; Doxorubicin; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dean Bajorin, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: June 10, 2003
• Study Start: March 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: April 1, 2009
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (285)