Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2015

Study Completion Date

May 20, 2022

Conditions
Esophageal Cancer
Interventions
DRUG

cetuximab

Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m\^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m\^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.

DRUG

cisplatin

Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m\^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.

DRUG

paclitaxel

Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m\^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.

RADIATION

radiation therapy

1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.

Trial Locations (175)

10025

St. Luke's - Roosevelt Hospital Center - St.Luke's Division, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

10591

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

12206

New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany

12801

Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls

13905

Lourdes Regional Cancer Center, Binghamton

15009

UPMC Cancer Center at Beaver Medical Center, Beaver

15025

UPMC Cancer Center at Jefferson Regional Medical Center, Clairton

15215

UPMC Cancer Center at UPMC St. Margaret, Pittsburgh

15237

UPMC Cancer Center at UPMC Passavant, Pittsburgh

15601

UPMC Cancer Center - Arnold Palmer Pavilion, Greensburg

16346

UPMC Cancer Center at UPMC Northwest, Seneca

16505

Regional Cancer Center - Erie, Erie

17325

Adams Cancer Center, Gettysburg

17405

York Cancer Center at Apple Hill Medical Center, York

19026

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill

19114

Frankford Hospital Cancer Center - Torresdale Campus, Philadelphia

19141

Albert Einstein Cancer Center, Philadelphia

19713

CCOP - Christiana Care Health Services, Newark

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21204

Greater Baltimore Medical Center Cancer Center, Baltimore

21229

St. Agnes Hospital Cancer Center, Baltimore

26003

Schiffler Cancer Center at Wheeling Hospital, Wheeling

27216

Alamance Cancer Center at Alamance Regional Medical Center, Burlington

28501

Kinston Medical Specialists, Kinston

28801

Mission Hospitals - Memorial Campus, Asheville

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29307

Cancer Centers of the Carolinas - Spartanburg, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29605

Cancer Centers of the Carolinas - Faris Road, Greenville

29615

CCOP - Greenville, Greenville

29672

Cancer Centers of the Carolinas - Seneca, Seneca

31405

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Savannah

31904

John B. Amos Cancer Center, Columbus

32806

M.D. Anderson Cancer Center at Orlando, Orlando

33140

CCOP - Mount Sinai Medical Center, Miami Beach

33176

Baptist-South Miami Regional Cancer Program, Miami

33458

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter

33805

Center for Cancer Care and Research at Watson Clinic, LLP, Lakeland

37916

Thompson Cancer Survival Center, Knoxville

39216

University of Mississippi Cancer Clinic, Jackson

40202

James Graham Brown Cancer Center at University of Louisville, Louisville

44060

Lake/University Ireland Cancer Center, Mentor

44109

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland

44122

UHHS Chagrin Highlands Medical Center, Orange

44130

Southwest General Health Center, Middleburg Heights

44145

UHHS Westlake Medical Center, Westlake

44203

Barberton Citizens Hospital, Barberton

44266

Robinson Radiation Oncology, Ravenna

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44708

Mercy Cancer Center at Mercy Medical Center, Canton

46016

Saint John's Cancer Center at Saint John's Medical Center, Anderson

46202

Methodist Cancer Center at Methodist Hospital, Indianapolis

46219

Central Indiana Cancer Centers - East, Indianapolis

46601

Memorial Hospital of South Bend, South Bend

46804

Radiation Oncology Associates Southwest, Fort Wayne

46805

Parkview Regional Cancer Center at Parkview Health, Fort Wayne

47403

Bloomington Hospital Regional Cancer Institute, Bloomington

48060

Mercy Regional Cancer Center at Mercy Hospital, Port Huron

48154

St. Mary Mercy Hospital, Livonia

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Genesys Hurley Cancer Institute, Flint

48601

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw

49503

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids

50010

McFarland Clinic, PC, Ames

50309

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines

50314

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines

50401

Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

53066

Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc

53188

Waukesha Memorial Hospital Regional Cancer Center, Waukesha

53295

Veterans Affairs Medical Center - Milwaukee, Milwaukee

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54303

St. Mary's Hospital Medical Center - Green Bay, Green Bay

54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau

55101

Regions Hospital Cancer Care Center, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology - Maplewood, Maplewood

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

56601

MeritCare Bemidji, Bemidji

57701

Rapid City Regional Hospital, Rapid City

58122

CCOP - MeritCare Hospital, Fargo

59405

Sletten Cancer Institute at Benefis Healthcare, Great Falls

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

62702

Cancer Institute at St. John's Hospital, Springfield

63110

Saint Louis University Cancer Center, St Louis

63131

Missouri Baptist Cancer Center, St Louis

63141

David C. Pratt Cancer Center at St. John's Mercy, St Louis

63703

Cancer Institute of Cape Girardeau, LLC, Cape Girardeau

68114

Methodist Estabrook Cancer Center, Omaha

68130

Lakeside Hospital, Omaha

70809

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

73104

Oklahoma University Cancer Institute, Oklahoma City

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

75090

Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman

75601

Longview Cancer Center, Longview

75702

Tyler Cancer Center, Tyler

76022

Texas Oncology, PA at Harris Center HEB, Bedford

76104

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth

76210

Texas Oncology, PA at Texas Cancer Center - Denton South, Denton

76310

Texas Oncology, PA - Wichita Falls, Wichita Falls

77024

Memorial Hermann Hospital - Memorial City, Houston

77479

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land

78217

Cancer Care Centers of South Texas - Northeast, San Antonio

79106

Harrington Cancer Center, Amarillo

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

80210

Porter Adventist Hospital, Denver

83706

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84770

Dixie Regional Medical Center - East Campus, St. George

85704

Arizona Oncology - Tucson, Tucson

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

93720

California Cancer Center - Woodward Park Office, Fresno

Saint Agnes Cancer Center at Saint Agnes Medical Center, Fresno

94589

Sutter Solano Medical Center, Vallejo

95355

Memorial Medical Center, Modesto

95603

Auburn Radiation Oncology, Auburn

95608

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael

95661

Radiation Oncology Center - Roseville, Roseville

95682

Radiation Oncology Centers - Cameron Park, Cameron Park

95687

Solano Radiation Oncology Center, Vacaville

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

95817

University of California Davis Cancer Center, Sacramento

95819

Mercy General Hospital, Sacramento

95926

Enloe Cancer Center at Enloe Medical Center, Chico

96813

Cancer Research Center of Hawaii, Honolulu

Queen's Cancer Institute at Queen's Medical Center, Honolulu

96817

Hawaii Medical Center - East, Honolulu

97015

Clackamas Radiation Oncology Center, Clackamas

97225

Providence St. Vincent Medical Center, Portland

97401

Willamette Valley Cancer Center - Eugene, Eugene

98684

Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver

06050

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain

06360

William W. Backus Hospital, Norwich

32610-0232

University of Florida Shands Cancer Center, Gainesville

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

61104-2315

Swedish-American Regional Cancer Center, Rockford

47303-3499

Cancer Center at Ball Memorial Hospital, Muncie

02721

Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River

48106-0995

Saint Joseph Mercy Cancer Center, Ann Arbor

49007-3731

West Michigan Cancer Center, Kalamazoo

59107-7000

Billings Clinic - Downtown, Billings

03301

Payson Center for Cancer Care at Concord Hospital, Concord

03820

Seacoast Cancer Center at Wentworth - Douglass Hospital, Dover

03833

Center for Cancer Care at Exeter Hospital, Exeter

03431

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

03103

Elliot Regional Cancer Center at Elliot Hospital, Manchester

07740-6395

Monmouth Medical Center, Long Branch

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

07871

Frederick R. and Betty M. Smith Cancer Treatment Center, Sparta

08755

J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

10003-3803

Beth Israel Medical Center - Petrie Division, New York

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

44710-1799

Aultman Cancer Center at Aultman Hospital, Canton

44106-5065

Case Comprehensive Cancer Center, Cleveland

97213-2967

Providence Cancer Center at Providence Portland Medical Center, Portland

15213-2582

UPMC - Shadyside, Pittsburgh

19612-6052

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading

02903

Rhode Island Hospital Comprehensive Cancer Center, Providence

02904

Northmain Radiation Oncology, Providence

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

79410-1894

Joe Arrington Cancer Research and Treatment Center, Lubbock

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

54235-1495

Door County Cancer Center at Door County Memorial Hospital, Sturgeon Bay

E2L 4L2

Saint John Regional Hospital, Saint John

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK

NCT00655876 - Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer | Biotech Hunter | Biotech Hunter