Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in Metastatic Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2009

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Bevacizumab

5 mg/kg over 30 minutes on Days 1 and 15

DRUG

Oxaliplatin

85 mg/m2 on Days 1 and 15

DRUG

Leucovorin

400 mg/m2 on Days 1 and 15

DRUG

Fluorouracil

400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)

DRUG

Cetuximab

400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour

Trial Locations (82)

10017

Memorial Sloan-Kettering Cancer Center, New York

11733

North Shore Hematology, East Setauket

12208

New York Oncology Hematology, PC, Albany

18704

Medical Oncology Associates, Kingston

20817

Center for Cancer & Blood Disorders, Bethesda

21044

Maryland Oncology Hematology, P.A., Columbia

21237

Auerbach Hematology Oncology Associated, Baltimore

23502

Virginia Oncology Associates, Norfolk

27511

Raleigh Hematology Oncology Associates, Cary

28602

Northwestern Carolina Ocology Hemato, Hickory

29605

Cancer Centers of the Carolinas, Greenville

29801

Cancer Center Associates of Carolina, PA / fka Carolina Cancer Center, Aiken

30224

Spalding Oncology Services, Griffin

30901

Medical Oncology Associates of Augusta PC, Augusta

32204

Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates, Jacksonville

32901

Melbourne Internal Medicine Associates, Melbourne

34474

Ocala Oncology Center, Ocala

34655

Florida Cancer Institute, New Port Richey

34761

Cancer Centers of Florida, P.A., Ocoee

35235

Brimingham Hematology and Oncology, Birmingham

38138

C. Michael Jones, MD, Germantown

45409

Greater Dayton Cancer Center, Kettering

46219

Central Indiana Cancer Centers, Indianapolis

46815

Fort Wayne Medical Oncology Hematology, Inc, Fort Wayne

47802

Hope Center, Terre Haute

48037

Osteopathic Medical Oncology and Hematology, Clinton Township

48144

Hematology Oncology Associates of Ohio & Michigan, Lambertville

49048

Kalamazoo Hematology & Oncology, Kalamazoo

52402

Iowa Blood and Cancer Care, Cedar Rapids

55404

Minnesota Oncology Hematology, PA, Minneapolis

60611

Hematology Oncology Associates of IL, Chicago

60714

Cancer Care & Hematology Specialists of Chicagoland, Niles

65201

Missouri Cancer Associates, Columbia

66210

Kansas City Cancer Centers-Southwest, Overland Park

67214

Cancer Center of Kansas, Wichita

70809

Louisiana Hematology Oncology Associates, Baton Rouge

75042

Texas Oncology, PA, Garland

75067

Lake Vista Cancer Center, Lewisville

75090

Texas Cancer Center-Sherman, Sherman

75150

Texas Cancer Center of Mesquite, Mesquite

75230

Texas Cancer Center at Medical City, Dallas

75231

Texas Oncology, PA, Dallas

75237

The Texas Cancer Center, Dallas

75246

Texas Oncology, PA, Dallas

75460

Paris Regional Cancer Center, Paris

75601

Longview Cancer Center, Longview

75702

Tyler Cancer Center, Tyler

76014

Texas Cancer Center, Arlington

76022

Texas Oncology, PA - Bedford, Bedford

76104

Texas Oncology, PA, Fort Worth

76210

Texas Cancer Center-Denton, Denton

76712

Waco Cancer Care and Research Center, Waco

77479

Texas Oncology Cancer Center-Sugar Land, Sugar Land

77598

Texas Oncology, P.A., Webster

Texas Oncology, PA, Webster

77702

Mamie McFaddin Ward Cancer Center, Beaumont

78229

HOAST - Medical Dr., San Antonio

78503

South Texas Cancer Center-McAllen, McAllen

78624

San Antonio Tumor & Blood Clinic, Fredericksburg

78731

Texas Oncology Cancer Center, Austin

79606

Texas Cancer Center-Abilene (Shouth), Abilene

79701

Allison Cancer Center, Midland

79761

West Texas Cancer Center, Odessa

79915

El Paso Cancer Treatment Ctr, El Paso

80218

Rocky Mountain Cancer Center-Midtown, Denver

80538

Greeley Medical Clinic Oncology Hematology, PC, Greeley

84106

Utah Cancer Specialists, Salt Lake City

85012

Hematology Oncology Associates, Phoenix

85715

Business Office - ACRC, Tucson

86336

Northern AZ Hematology & Oncology Assoc, Sedona

89109

Comprehensive Cancer Centers of Nevada, Las Vegas

Nevada Cancer Centers, Las Vegas

93720

Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care), Fresno

93940

Monterey Bay Oncology, Monterey

97401

Willamette Valley Cancer Center, Eugene

98026

Puget Sound Cancer Center-Edmonds, Edmonds

98133

Puget Sound Cancer Center Seattle, Seattle

98684

Northwest Cancer Specialists-Vancouver, Vancouver

98902

Yakima Valley mem Hosp/North Star Lodge, Yakima

99202

Cancer Care Northwest-South, Spokane

06790

Connecticut Oncology & Hematology, LLP, Torrington

07960

Hematology-Oncology Associates of NNJ, PA, Morristown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Memorial Sloan Kettering Cancer Center

OTHER

collaborator

Prologue Research International

INDUSTRY

lead

US Oncology Research

INDUSTRY