Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Adenocarcinoma of the Colon, Stage III Colon Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the colon Stage III disease No resected stage IV disease No rectal cancer Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopy Stage III tumor must have been completely resected within the past 56 days Must have documented en bloc resection in patients with tumor adherence to adjacent structures Tumor-related obstructions and colonic perforation are allowed Tumor samples must be available At least 1 pathologically confirmed positive lymph node No evidence of residual involved lymph node disease Synchronous primary colon cancer allowed No distant metastatic disease Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) Creatinine ≤ 1.5 times ULN No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No myocardial infarction with the past 6 months No New York Heart Association class III or IV heart disease No symptomatic pulmonary fibrosis No symptomatic interstitial pneumonitis No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy No known allergy to platinum compounds No documented presence of human anti-mouse antibodies (HAMA) No active uncontrolled bacterial, viral, or systemic fungal infection HIV negative No clinically defined AIDS Not pregnant or nursing Negative pregnancy test No men or women of childbearing potential who are unwilling to employ adequate contraception No inadequately treated gastrointestinal bleeding No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in situ in 1 breast No other concurrent medical condition that would preclude study participation No concurrent biologic therapy No prior chemotherapy for colon cancer No other concurrent chemotherapy No prior radiotherapy for colon cancer No concurrent targeted agents No prior agents directed against epidermal growth factor-receptor No other concurrent anticancer therapy
Sites / Locations
- Northeast Alabama Regional Medical Center
- Clearview Cancer Institute
- Mobile Infirmary Medical Center
- Providence Hospital
- Providence Alaska Medical Center
- Banner Thunderbird Medical Center
- Banner Desert Medical Center
- Banner Baywood Medical Center
- Banner Good Samaritan Medical Center
- Western Regional CCOP
- Phoenix Indian Medical Center
- Scottsdale Healthcare
- Mayo Clinic in Arizona
- Highlands Oncology Group-Bentonville
- Saint Edward Mercy Medical Center
- University of Arkansas for Medical Sciences
- Veteran's Administration Medical Center
- Alta Bates Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center
- Mills - Peninsula Hospitals
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- City of Hope
- Northbay Cancer Center
- Kaiser Permanente, Fremont
- Valley Medical Oncology Consultants-Fremont
- California Cancer Center - North Fresno
- Cancer Care Associates
- California Cancer Care - Greenbrae
- Sutter Health Western Division Cancer Research Group
- Kaiser Permanente, Hayward
- Saint Rose Hospital
- Loma Linda University Medical Center
- University of Southern California
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Community Hospital of Monterey Peninsula
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons Inc
- Bay Area Tumor Institution CCOP
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Saint Joseph Hospital
- Desert Regional Medical Center
- Palo Alto Medical Foundation Heath Care
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Shasta Regional Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- Sutter General Hospital
- UC Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente
- Naval Medical Center -San Diego
- University of California San Diego - Veterans Administration
- Kaiser Permanente-San Francisco
- University of California San Francisco Medical Center-Mount Zion
- California Pacific Medical Center
- Kaiser Permanente-Santa Teresa-San Jose
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Santa Rosa Memorial Hospital
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Tahoe Forest Cancer Center
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente-Walnut Creek
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Memorial Hospital Colorado Springs
- Saint Anthony Central Hospital
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Bridgeport Hospital
- Danbury Hospital
- Hartford Hospital
- Saint Francis Hospital and Medical Center
- Manchester Memorial Hospital
- Middlesex Hospital
- The Hospital of Central Connecticut
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital
- Bayhealth Medical Center at Kent General
- Beebe Medical Center
- Washington Hospital Center
- Lombardi Comprehensive Cancer Center at Georgetown University
- Howard University Hospital
- Halifax Medical Center-Centers for Oncology
- North Broward Medical Center
- Broward General Medical Center
- University of Florida
- Edna Williams Cancer Center at the Baptist Cancer Institute
- Mayo Clinic in Florida
- The Watson Clinic
- Cancer Centers of Central Florida PA
- Baptist Hospital of Miami
- Integrated Community Oncology Network - Orange Park Cancer Center
- Florida Hospital
- M D Anderson Cancer Center- Orlando
- Sacred Heart Hospital
- Sacred Heart Medical Oncology Group - Davis Highway
- Montgomery and Associates MD PA
- Florida Cancer Specialists - Sarasota Downtown
- Martin Memorial Cancer Center
- Martin Memorial Medical Center - North
- Martin Memorial Hospital - South
- Palm Beach Cancer Institute-Main Office
- Phoebe Putney Memorial Hospital
- Piedmont Hospital
- Atlanta Regional CCOP
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Augusta Oncology Associates PC
- Well Star Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Veterans Administration Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Memorial Health University Medical Center
- Saint Joseph's-Candler Health System
- South Georgia Medical Center
- Kapiolani Medical Center at Pali Momi
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii
- Hawaii Medical Center East
- Oncare Hawaii Inc-Kuakini
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Alphonsus Regional Medical Center
- Saint Luke's Mountain States Tumor Institute
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- Hematology and Oncology Associates
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- Resurrection Healthcare
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Illinois Masonic Medical Center
- Decatur Memorial Hospital
- Saint Anthony Memorial Hospital
- Sherman Hospital
- Cancer Institute at Alexian Brothers
- Eureka Hospital
- Evanston CCOP-NorthShore University HealthSystem
- Saint Francis Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Intercommunity Cancer Center
- Ingalls Memorial Hospital
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Midwest Center for Hematology Oncology
- Joliet Oncology-Hematology Associates Limited
- Provena Saint Mary's Hospital
- Kewanee Hospital
- La Grange Memorial Hospital
- Deerpath Medical Associates
- North Shore Hematology Oncology
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Trinity Medical Center
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
- Good Samaritan Regional Medical Center
- Hematology Oncology Consultants Limited
- Edward Hospital
- Cancer Care and Hematology Specialists of Chicagoland PC
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- West Suburban Cancer Center
- Swedish American Hospital
- Sarah Culbertson Memorial Hospital
- Edward H Kaplan MD and Associates
- Hematology Oncology Associates of Illinois - Skokie
- Midwest Cancer Research Group Incorporated
- Saint Margaret's Hospital
- Valley Cancer Center
- Memorial Medical Center
- Carle Clinic-Urbana Main
- Carle Foundation dba Carle Cancer Center
- Saint Francis Hospital and Health Centers
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
- Indiana University Medical Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Wishard Hospital
- Saint Vincent Hospital and Health Services
- Howard Regional Healthcare System
- Laporte Hospital
- Clarian Arnett Cancer Care
- Premier Oncology Hematology Associates
- Saint Anthony Memorial Health Center
- Ball Memorial Hospital
- The Community Hospital
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- Saint Joseph's Medical Center
- South Bend Clinic
- McFarland Clinic
- Constantinou, Costas L MD (UIA Investigator)
- Hematology Oncology Associates-Quad Cities
- Saint Anthony Regional Hospital
- Iowa Blood and Cancer Care PLC
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates
- Medical Oncology and Hematology Associates-West Des Moines
- Alegent Health Mercy Hospital
- Genesis Medical Center - East Campus
- Genesis Medical Center - West Campus
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Finley Hospital
- University of Iowa Hospitals and Clinics
- Mercy Medical Center - North Iowa
- Community Memorial Hospital
- Burgess Memorial Hospital
- Siouxland Regional Cancer Center
- Siouxland Hematology - Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Covenant Medical Center
- Memorial Hospital of Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Medical Center
- Cancer Center of Kansas - Ottawa
- Menorah Medical Center
- Radiation Oncology Practice Corporation Southwest
- Cancer Center of Kansas - Parsons
- Mount Carmel Regional Cancer Center
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Shawnee Mission Medical Center
- Stormont-Vail Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Our Lady Bellefonte Hospital
- Central Baptist Hospital
- University of Louisville
- Merle Mahr Cancer Center
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Ochsner Clinic Foundation-Baton Rouge
- DeSoto Regional Health System
- Metairie Oncologists
- Louisiana State University Sciences Center- Monroe
- Louisiana State University Health Science Center
- Medical Center of Louisiana
- Ochsner Clinic CCOP
- Ochsner Clinic Foundation
- Highland Clinic
- Louisiana State University
- Eastern Maine Medical Center
- Anne Arundel Medical Center
- Greater Baltimore Medical Center
- The Union Memorial Hospital
- Franklin Square Hospital Center
- Good Samaritan Hospital of Maryland
- Johns Hopkins University
- Union Hospital of Cecil County
- Frederick Memorial Hospital
- Washington County Hospital
- Associates in Oncology Hematology PC -Kensington
- Associates In Oncology Hematology PC-Rockville
- Beverly Hospital
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Caritas Saint Elizabeth's Medical Center
- Addison Gilbert Hospital
- Franklin Medical Center
- Holyoke Medical Center
- Lowell General Hospital
- Lawrence Memorial
- Holy Family Hospital
- Metrowest Medical Center Incorporated
- Norwood Hospital
- North Shore Medical Center Cancer Center
- Berkshire Hematology Oncology PC
- Commonwealth Hematology Oncology PC-Quincy
- South Shore Hospital
- Baystate Medical Center
- Morton Hospital and Medical Center
- Noble Hospital
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Battle Creek Health System
- Bay Regional Medical Center
- Mecosta County Medical Center
- Oakwood Hospital
- Wayne State University
- Saint John Hospital and Medical Center
- Michigan State University - Breslin Cancer Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center
- McLaren Regional Medical Center
- Grand Rapids Clinical Oncology Program
- Saint Mary's Health Care
- Spectrum Health at Butterworth Campus
- Spectrum Health-Blodgett Campus
- Holland Community Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Kalamazoo Center for Medical Studies
- Ingham Regional Medical Center
- Sparrow Hospital
- Lapeer Regional Hospital
- Saint Mary Mercy Hospital
- Mid-Michigan Medical Center - Midland
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Mercy Health Partners-Hackley Campus
- Mercy Health Partners-Mercy Campus
- Northern Michigan Regional Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- William Beaumont Hospital
- Saint Mary's of Michigan
- Lakeland Hospital
- Providence Hospital
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Metro Health Hospital
- Harris, John Gilbert MD (UIA Investigator)
- Medini, Eitan MD (UIA Investigator)
- Merit Care Clinic Bemidji
- Brainerd Medical Center Inc
- Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Duluth Clinic CCOP
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Saint Mary's Medical Center
- Fairview-Southdale Hospital
- Etzell, Paul S MD (UIA Investigator)
- Swenson, Wade II, MD (UIA Investigator)
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Immanuel-Saint Joseph Hospital-Mayo Health System
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Minneapolis Veterans Medical Center
- Chippewa County - Montevideo Hospital
- North Memorial Medical Health Center
- Mayo Clinic
- CentraCare Clinic
- Saint Cloud Hospital
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Adult and Pediatric Urology PLLP
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Woodwinds Health Campus
- Veterans Affairs Medical Center
- Keesler Medical Center
- Singing River Hospital
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Missouri Cancer Associates
- Independence Regional Health Center
- Freeman Health System
- Saint John's Regional Medical Center
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- Radiation Oncology Practice Corporation South
- Saint Joseph Health Center
- Liberty Radiation Oncology Clinic
- North Kansas City Hospital
- Kansas City Veterans Affairs Medical Center
- Research Medical Center
- Radiation Oncology Practice Corporation - North
- Liberty Hospital
- Missouri Cancer Care PC - Saint Charles
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute
- Saint Louis University Hospital
- Washington University School of Medicine
- Saint Anthony's Medical Center
- Missouri Baptist Medical Center
- Christian Hospital Northeast - Northwest
- Center for Cancer Care and Research
- Saint John's Mercy Medical Center
- Saint Louis-Cape Girardeau CCOP
- Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
- Saint John's Hospital
- Cox Medical Center
- Hematology-Oncology Centers of the Northern Rockies PC
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Billings Clinic
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Big Sky Oncology
- Great Falls Clinic
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Fremont Area Medical Center
- Saint Francis Medical Center
- Good Samaritan Hospital
- Bryan LGH Medical Center West
- Bryan LGH Medical Center East
- Lincoln Medical Education Foundation Cancer Resource Center
- Saint Elizabeth Regional Medical Center
- Great Plains Regional Medical Center
- Missouri Valley Cancer Consortium CCOP
- Methodist Estabrook Cancer Center
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- University Medical Center of Southern Nevada
- Nevada Cancer Research Foundation CCOP
- Nevada Cancer Institute
- New Hampshire Oncology-Hematology PA
- Columbia Parkland Medical Center
- Exeter Hospital
- New Hampshire Oncology Hematology Associates
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- Elliot Hospital
- Portsmouth Regional Hospital
- Ocean Medical Center
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Englewood Hospital and Medical Center
- Hunterdon Medical Center
- CentraState Medical Center
- Cancer Institute of New Jersey At Hamilton
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Mountainside Hospital
- Morristown Memorial Hospital
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Cancer Institute of New Jersey
- Warren Hospital
- Booker Cancer Center at Riverview Medical Center
- Somerset Medical Center
- Sparta Cancer Treatment Center
- Overlook Hospital
- South Jersey Healthcare
- Virtua West Jersey Hospital Voorhees
- University of New Mexico at Lovelace Medical Center
- Hematology Oncology Associates
- University of New Mexico
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- New Mexico Cancer Care Associates
- Albert Einstein College of Medicine
- The North Division of Montefiore Medical Center
- Montefiore Medical Center
- Long Island College Hospital
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York
- Adirondack Cancer Center
- Catskill Regional Medical Center
- Orange Regional Medical Center
- Winthrop University Hospital
- Beth Israel Medical Center
- New York University Langone Medical Center
- Saint Luke's Roosevelt Hospital Center - Saint Luke's Division
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- Nyack Hospital
- Highland Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- State University of New York Upstate Medical University
- Faxton-Saint Luke's Healthcare
- Dickstein Cancer Treatment Center
- Mission Hospitals Inc
- Alamance Regional Medical Center
- University of North Carolina
- Carolinas Medical Center
- Gaston Memorial Hospital
- Southeastern Medical Oncology Center
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Margaret R Pardee Memorial Hospital
- Kinston Medical Specialists PA
- Rutherford Hospital
- Iredell Memorial Hospital
- Marion L Shepard Cancer Center
- New Hanover Regional Medical Center
- Wilson Medical Center
- Bismarck Cancer Center
- Medcenter One Health Systems
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Veterans Administration Medical Center
- Innovis Health South University
- Meritcare Hospital
- MeritCare Medical Group
- Altru Cancer Center
- Trinity Cancer Care Center
- Akron City Hospital
- Akron General Medical Center
- Summa Barberton Hospital
- Mary Rutan Hospital
- The Boardman Cancer Center
- Wood County Oncology Center
- Mercy Medical Center
- Aultman Health Foundation
- Adena Regional Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University Medical Center
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Veteran Affairs Medical Center
- Dayton CCOP
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Fremont Memorial Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Cole, Sharon, K. M.D. (UIA Investigator)
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Lima Memorial Hospital
- Mansfield General Hospital-MedCentral Health System
- Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- Saint Luke's Hospital
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Licking Memorial Hospital
- Bayview Oncology Associates
- Saint Charles Hospital
- Cancer Care Center, Incorporated
- Firelands Regional Medical Center
- North Coast Cancer Care
- Community Hospital Springfield
- Flower Memorial Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Cancer Center at Saint Anne Mercy Hospital
- Toledo Clinic
- Upper Valley Medical Center
- Saint Joseph Cancer Center
- Fulton County Health Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Cancer Treatment Center
- Cleveland Clinic Wooster Specialty Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Saint Elizabeth Hospital Medical Center
- Genesis HealthCare System
- Cancer Centers of Southwest Oklahoma Research - Lawton
- University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Natalie W Bryant Cancer Center
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Adventist Medical Center
- Columbia River Oncology Program
- Providence Saint Vincent Medical Center
- Legacy Emanuel Hospital and Health Center
- Northwest Cancer Specialists-Rose Quarter Cancer Center
- Kaiser Permanente
- Oregon Health and Science University
- Salem Hospital
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital
- Saint Luke's Hospital
- Bryn Mawr Hospital
- Marion Community Hospital
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Doylestown Hospital
- Delaware County Memorial Hospital
- Pocono Medical Center
- Easton Hospital
- Ephrata Cancer Center
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
- Geisinger South Wilkes Barre-Hazelton Cancer Center
- Lancaster General Hospital
- Central PA Hematology-Medical Oncology Associates PC
- Riddle Hospital
- Paoli Memorial Hospital
- Abramson Cancer Center of The University of Pennsylvania
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Aria Health-Torresdale Campus
- Albert Einstein Medical Center
- Allegheny Cancer Center at Allegheny General Hospital
- University of Pittsburgh
- Western Pennsylvania Hospital
- Pottstown Memorial Medical Center
- Saint Joseph Medical Center
- Guthrie Clinic - Sayre
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Community Medical Center
- Moses Taylor Hospital
- Scranton Hematology Oncology
- Grand View Hospital
- Geisinger Medical Group
- Mount Nittany Medical Center
- Associates In Hematology Oncology PC-Upland
- Jennersville Regional Hospital
- Reading Hospital and Medical Center
- Geisinger Wyoming Valley
- Lankenau Hospital
- Mainline Health CCOP
- Hematology and Oncology Associates of Rhode Island Inc
- Rhode Island Hospital
- Miriam Hospital
- Kent County Hospital
- AnMed Health Hospital
- Medical University of South Carolina
- Greenville Memorial Hospital
- Greenville CCOP
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Conklin Regional Cancer Center
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Sanford University of South Dakota Medical Center
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- Veterans Affairs Medical Center - Memphis
- Tennessee Oncology PLLC- Centennial Medical Center
- Meharry Medical College
- Vanderbilt University
- The Don and Sybil Harrington Cancer Center
- Texas Health Presbyterian Hospital Dallas
- The Center for Integrative Cancer Medicine
- Brooke Army Medical Center
- University of Texas Medical Branch
- Baylor College of Medicine
- Ben Taub General Hospital
- Methodist Hospital
- Saint Luke's Episcopal Hospital
- Veterans Administration Medical Center
- Wilford Hall Medical Center
- Doctor's Hospital of Laredo
- Audie L Murphy Veterans Affairs Hospital
- University of Texas Health Science Center
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- South Texas Oncology and Hematology PA
- University Hospital
- Scott and White Memorial Hospital
- Southwestern Oncology Research Department
- University of Vermont
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Riverside Middle Peninsula Cancer Center
- Lynchburg Hematology-Oncology Clinic
- Peninsula Cancer Institute-Newport News
- Southwest VA Regional Cancer Center
- Peninsula Cancer Institute
- Auburn Regional Medical Center
- Saint Joseph Hospital
- Harrison Bremerton Hematology and Oncology
- Providence Centralia Hospital
- Saint Francis Hospital
- Columbia Basin Hematology and Oncology PLLC
- Evergreen Hospital Medical Center
- Providence - Saint Peter Hospital
- Capital Medical Center
- Olympic Medical Center
- Good Samaritan Community Hospital
- Valley Medical Center
- Virginia Mason CCOP
- Minor and James Medical PLLC
- Puget Sound Oncology Consortium
- Group Health Cooperative
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Sacred Heart Medical Center
- Holy Family Hospital
- Allenmore Hospital
- Northwest CCOP
- Saint Joseph Medical Center
- Tacoma General Hospital
- Multicare Health System
- Saint Clare Hospital
- Southwest Washington Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Edwards Comprehensive Cancer Center
- West Virginia University
- Camden-Clark Memorial Hospital
- Princeton Community Hospital
- Wheeling Hospital
- Langlade Hospital and Cancer Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Sacred Heart Hospital
- Midelfort Clinic-Clairemont Campus
- Mayo Clinic Health System Eau Claire Hospital - Luther Campus
- Central Wisconsin Cancer Program
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- Mercy Health System
- UW Cancer Center Johnson Creek
- Franciscan Skemp Healthcare
- UW Health Oncology - 1 South Park
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Bay Area Medical Center
- Vince Lombardi Cancer Clinic-Marinette
- Marshfield Clinic
- Saint Joseph's Hospital
- Marshfield Clinic-Minocqua Center
- Oconomowoc Memorial Hospital-ProHealth Care Inc
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic at James Beck Cancer Center
- Marshfield Clinic-Rice Lake Center
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Welch Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Lions Gate Hospital
- BCCA-Fraser Valley Cancer Centre
- BCCA-Vancouver Cancer Centre
- CancerCare Manitoba
- The Moncton Hospital
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- The Royal Victoria Hospital
- Cambridge Memorial Hospital
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Grand River Regional Cancer Centre at Grand River Hospital
- London Regional Cancer Program
- Credit Valley Hospital
- Ottawa Health Research Institute-General Division
- Algoma District Cancer Program Sault Area Hospital
- Niagara Health System-Saint Catharines General
- Regional Cancer Program of The Hopital Regional de Sudbury Regional Hopital
- Thunder Bay Regional Health Science Centre
- Toronto East General Hospital
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Saint Michael's Hospital
- Mount Sinai Hospital
- University Health Network-Princess Margaret Hospital
- Trillium Health Centre-West Toronto
- Windsor Regional Cancer Centre
- PEI Cancer Treatment Centre-Queen Elizabeth Hospital
- McGill University Department of Oncology
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Andres Grillasca Hospital
- Hato Rey Hematology Oncology Group
- I Gonzales Martinez-Oncologic Hospital
- San Juan Veterans Affairs Medical Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Other
Arm A (combination chemotherapy)
Arm B (combination chemotherapy)
Arm C (combination chemotherapy)
Arm D (combination chemotherapy, monoclonal antibody)
Arm E (combination chemotherapy, monoclonal antibody)
Arm F (combination chemotherapy, monoclonal antibody)
Arm G (Locally directed therapy)
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
Patients received cetuximab as in arm D and chemotherapy as in arm C.
Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.