S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

November 30, 2002

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions
Bladder CancerUrethral Cancer
Interventions
DRUG

carboplatin

\*AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

DRUG

cisplatin

75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)

DRUG

gemcitabine hydrochloride

800 mg/m2, IV, over 30 minutes; given on Days 1 \& 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)

DRUG

paclitaxel

200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

PROCEDURE

neoadjuvant therapy

Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)

RADIATION

radiation therapy

Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.

Trial Locations (92)

10016

NYU Cancer Institute at New York University Medical Center, New York

10032

Herbert Irving Comprehensive Cancer Center at Columbia University, New York

14220

Western New York Urology Associates, Buffalo

14642

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

20060

MBCCOP - Howard University Cancer Center, Washington D.C.

29303

CCOP - Upstate Carolina, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29615

CCOP - Greenville, Greenville

33612

Veterans Affairs Medical Center - Tampa (Haley), Tampa

36607

MBCCOP - Gulf Coast, Mobile

38104

University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis

39216

Veterans Affairs Medical Center - Jackson, Jackson

43206

CCOP - Columbus, Columbus

45429

CCOP - Dayton, Dayton

48075

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48202

Josephine Ford Cancer Center at Henry Ford Health System, Detroit

49503

CCOP - Grand Rapids, Grand Rapids

59101

CCOP - Montana Cancer Consortium, Billings

60141

Veterans Affairs Medical Center - Hines, Hines

60612

MBCCOP - University of Illinois at Chicago, Chicago

Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago

62526

CCOP - Central Illinois, Decatur

63110

Saint Louis University Cancer Center, St Louis

63141

CCOP - St. Louis-Cape Girardeau, St Louis

64131

CCOP - Kansas City, Kansas City

65807

CCOP - Cancer Research for the Ozarks, Springfield

67218

Veterans Affairs Medical Center - Wichita, Wichita

70112

MBCCOP - LSU Health Sciences Center, New Orleans

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans

Veterans Affairs Medical Center - New Orleans, New Orleans

72205

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock

Veterans Affairs Medical Center - Little Rock, Little Rock

73104

Oklahoma University Medical Center, Oklahoma City

76504

Veterans Affairs Medical Center - Temple, Temple

76508

CCOP - Scott and White Hospital, Temple

77030

Baylor College of Medicine, Houston

78229

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio

79106

Harrington Cancer Center, Amarillo

Texas Tech University Health Sciences Center School of Medicine, Amarillo

Veterans Affairs Medical Center - Amarillo, Amarillo

80010

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora

80220

Veterans Affairs Medical Center - Denver, Denver

84148

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City

85012

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix

85723

Veterans Affairs Medical Center - Tucson, Tucson

85724

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson

87131

MBCCOP - University of New Mexico HSC, Albuquerque

90033

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

92868

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange

94553

Veterans Affairs Outpatient Clinic - Martinez, Martinez

95403

CCOP - Santa Rosa Memorial Hospital, Santa Rosa

95817

University of California Davis Cancer Center, Sacramento

96813

MBCCOP - Hawaii, Honolulu

97225

CCOP - Columbia River Oncology Program, Portland

98101

CCOP - Virginia Mason Research Center, Seattle

98108

Veterans Affairs Medical Center - Seattle, Seattle

98109

Puget Sound Oncology Consortium, Seattle

85006-2726

CCOP - Western Regional, Arizona, Phoenix

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

90095-1781

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles

94609-3305

CCOP - Bay Area Tumor Institute, Oakland

30342-1701

CCOP - Atlanta Regional, Atlanta

60153-5500

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

66160-7390

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City

67214-3882

CCOP - Wichita, Wichita

40502-2236

Veterans Affairs Medical Center - Lexington, Lexington

40536-0084

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington

71101-4295

Veterans Affairs Medical Center - Shreveport, Shreveport

71130-3932

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport

02118

Cancer Research Center at Boston Medical Center, Boston

48109-0946

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

48201-1932

Veterans Affairs Medical Center - Detroit, Detroit

48073-6769

CCOP - Beaumont, Royal Oak

39216-4505

University of Mississippi Medical Center, Jackson

87108-5138

Veterans Affairs Medical Center - Albuquerque, Albuquerque

27534-9479

CCOP - Southeast Cancer Control Consortium, Goldsboro

45220-2288

Veterans Affairs Medical Center - Cincinnati, Cincinnati

45267-0501

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

44195-9001

Cleveland Clinic Taussig Cancer Center, Cleveland

45428-1002

Veterans Affairs Medical Center - Dayton, Dayton

97201-3098

Cancer Institute at Oregon Health and Science University, Portland

29401-5799

Veterans Affairs Medical Center - Charleston, Charleston

78234-6200

Brooke Army Medical Center, Fort Sam Houston

77555-0565

University of Texas Medical Branch, Galveston

77030-4095

M.D. Anderson Cancer Center at University of Texas, Houston

79415-3364

UMC Southwest Cancer and Research Center, Lubbock

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

84112-5550

Huntsman Cancer Institute at University of Utah, Salt Lake City

23510-1115

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk

98405-0986

CCOP - Northwest, Tacoma

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT00055835 - S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium | Biotech Hunter | Biotech Hunter