Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage III colon cancer, stage III rectal cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
Locally Advanced or Metastatic Colorectal Cancer Eligible patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have either locally advanced (unresectable) or metastatic disease. Patients with resected primary tumors who have documented metastases are eligible. Documentation of residual disease by CT scan or surgeon's notes is required for all patients, and histologic confirmation of metastases is strongly encouraged. Patients with a history of colorectal cancer treatment by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless: Either an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease or The primary cancer was stage I. Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. At the time of randomization, the intent of this treatment must be indicated palliative or neoadjuvant chemotherapy with the potential for resection of all sites of metastatic disease. Only patients with a wildtype K-ras gene as determined by the laboratory at the SWOG Solid Tumor Repository or by a local CLIA-certified laboratory are eligible. Patients with a mutation in the K-ras gene are ineligible. All patients must have available for analysis of K-ras status at least one H and E slide and one paraffin block of the previously resected primary colorectal tumor and/or a tumor deposit. For patients registered and randomized based on local CLIA-certified laboratory results, SWOG analysis will be confirmatory only. Prior Treatment No prior systemic treatment for advanced or metastatic colorectal cancer is allowed. Prior regional chemotherapy (eg, hepatic arterial infusion) is also not allowed. Patients may have received prior adjuvant chemotherapy that included fluorouracil alone or in combination with fluorouracil and oxaliplatin or irinotecan (no more than 6 months); or radiation with radiosensitizing chemotherapy. The last course of adjuvant chemotherapy must have concluded > 12 months prior to colorectal cancer recurrence. Patients may have received neoadjuvant chemo-radiation with capecitabine or 5-fluorouracil. Patients may not have received itraconazole or ketoconazole less than 4 weeks prior to randomization. No prior exposure to any tyrosine kinase inhibitors or other agents (including protein products, monoclonal antibodies, antisense, etc.) that target VEGF or EGF receptors is allowed. No prior treatment with bevacizumab or cetuximab. Patients may not have had prior radiotherapy to greater than 25% of bone marrow. (Standard adjuvant rectal cancer chemoradiation will not exclude patient from protocol entry.) Radiation must have concluded ≥ 4 weeks prior to randomization. Patients should have completed any major surgery ≥ 4 weeks from randomization. Patients must have completed any minor surgery ≥ 2 weeks prior to randomization. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery.) No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years. For patients who are to receive FOLFIRI: No evidence of Gilbert's Syndrome or of homozygosity for the UGT1A1*28 allele. Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38. Evidence of Gilbert's Syndrome would include a prior finding of an isolated elevation of indirect bilirubin. UGT1A1 genotyping is not required on this study. However, patients known to be homozygous for the UGT1A1*28 allele are not to receive FOLFIRI for this study. Patients with Gilbert's Syndrome or who are found to be homozygous for the UGT1A1 allele who will receive FOLFOX are eligible. No sensory peripheral neuropathy of ≥ grade 2 at baseline for patients who are to receive FOLFOX. No known central nervous system metastases or carcinomatous meningitis. No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung. No pleural effusion or ascites that causes ≥ grade 2 dyspnea. No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may entered at investigator discretion. Patients must not have an uncontrolled seizure disorder, or active neurological disease. No current congestive heart failure (New York Heart Association Class II, III or IV) Patients with history of hypertension must be well controlled ( < 160/90) on a regimen of anti-hypertensive therapy. Patients on full-dose anticoagulation (eg, warfarin) are eligible provided that both of the following criteria are met: The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin. The patient has no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices). Patients receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible. No significant history of bleeding events or GI perforation: Patients with a history of significant bleeding episodes (eg, hemoptysis, upper or lower GI bleeding ) within 6 months of randomization are not eligible unless the source of bleeding has been resected. Patients with a history of GI perforation within 12 months of randomization are not eligible. No arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI). Patients with clinically significantly peripheral artery disease (eg, claudication on less than one block) or any other arterial thrombotic event are also ineligible. No serious or non-healing wound, ulcer or bone fracture Patients with known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies are not eligible. Non-pregnant and not nursing: Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. DNA alkylating agents are known to be teratogenic, and the effects of irinotecan, oxaliplatin, 5-FU, bevacizumab, and cetuximab on a developing fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL. Women of child-bearing potential also include women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential. ECOG Performance Status of 0-1 Age ≥ 18 years Required Initial Laboratory Values: Granulocytes ≥ 1500 µL Hemoglobin ≥ 9.0 grams/dL (patient may be transfused to meet this criterion) Platelet count ≥ 100,000/µL Creatinine ≤ 1.5 x Upper limits of normal Bilirubin ≤ 1.5 mg/dL Albumin ≥ 2.5 g/dL Urinalysis ≤ 1 + protein* *Patients discovered to have ≥ 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hour or have a UPC < 1.0 to allow participation in the study.
Sites / Locations
- Providence Cancer Center at Providence Hospital
- Alaska Regional Hospital Cancer Center
- Providence Cancer Center
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- NEA Medical Center - Stadium Boulevard
- Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants - Castro Valley
- North Bay Cancer Center
- Kaiser Permanente - Fremont
- Valley Medical Oncology
- Glendale Memorial Hospital Comprehensive Cancer Center
- California Cancer Care, Incorporated - Greenbrae
- Kaiser Permanente Medical Center - Hayward
- Veterans Affairs Medical Center - Loma Linda (Pettis)
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Camino Medical Group - Treatment Center
- El Camino Hospital Cancer Center
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Kaiser Permanente Medical Center - Oakland
- St. Joseph Hospital Regional Cancer Center - Orange
- Desert Regional Medical Center Comprehensive Cancer Center
- Palo Alto Medical Foundation
- Valley Medical Oncology Consultants - Pleasanton
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Kaiser Permanente Medical Center - Roseville
- University of California Davis Cancer Center
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Saint Helena Hospital
- Kaiser Permanente Medical Office -Vandever Medical Office
- Naval Medical Center - San Diego
- San Francisco General Hospital Medical Center
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- UCSF Helen Diller Family Comprehensive Cancer Center
- Kaiser Permanente Medical Center - Santa Teresa
- Kaiser Foundation Hospital - San Rafael
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Kaiser Permanente Medical Center - South San Francisco
- Kaiser Permanente Medical Facility - Stockton
- Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center - Vallejo
- Kaiser Permanente Medical Center - Walnut Creek
- San Luis Valley Regional Medical Center
- Aurora Presbyterian Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Boulder Community Hospital
- Memorial Hospital Cancer Center - Colorado Springs
- Penrose Cancer Center at Penrose Hospital
- Denver Health Medical Center
- St. Anthony Central Hospital
- Kaiser Permanente - Denver
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- Veterans Affairs Medical Center - Denver
- CCOP - Colorado Cancer Research Program
- Shaw Regional Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Valley View Hospital Cancer Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Kaiser Permanente - Lafayette
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- Montrose Memorial Hospital Cancer Center
- Parker Adventist Hospital
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Bendheim Cancer Center at Greenwich Hospital
- Helen and Harry Gray Cancer Center at Hartford Hospital
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Middlesex Hospital Cancer Center
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- Eastern Connecticut Hematology and Oncology Associates
- Kent General Hospital
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- Sibley Memorial Hospital
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- Memorial Cancer Institute at Memorial Regional Hospital
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- Sacred Heart Medical Oncology
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Northeast Georgia Cancer Care, LLC - Medical Oncology
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- MBCCOP - Medical College of Georgia Cancer Center
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Dublin Hematology and Oncology Care
- Piedmont Fayette Hospital
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Medical Center of Central Georgia
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Hawaii Medical Center - East
- OnCare Hawaii, Incorporated - Kuakini
- Kaiser Permanente - Moanalua Medical Center and Clinic
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- John H. Stroger, Jr. Hospital of Cook County
- Resurrection Medical Center
- University of Chicago Cancer Research Center
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
- Saint Joseph Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Alexian Brothers Radiation Oncology
- Elmhurst Memorial Hospital
- Evanston Hospital
- St. Francis Hospital
- Leonard C. Ferguson Cancer Center
- Veterans Affairs Medical Center - Hines
- Joliet Oncology-Hematology Associates, Limited - West
- Provena St. Mary's Regional Cancer Center - Kankakee
- La Grange Memorial Hospital
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Edward Hospital Cancer Center
- Hematology Oncology Consultants - Naperville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- West Suburban Center for Cancer Care
- Swedish-American Regional Cancer Center
- Center for Cancer Care at OSF Saint Anthony Medical Center
- Hematology Oncology Associates - Skokie
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- St. Vincent Indianapolis Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Clarian Arnett Cancer Care
- Suniti Medical Corporation
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Community Hospital
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC - La Porte
- McFarland Clinic, PC
- Hematology Oncology Associates of the Quad Cities
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Heartland Oncology and Hematology
- Genesis Regional Cancer Center at Genesis Medical Center
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Veterans Affairs Medical Center - Iowa City
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Covenant Cancer Treatment Center
- Hays Medical Center
- Hutchinson Hospital Corporation
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Menorah Medical Center
- Saint Luke's Hospital - South
- Mount Carmel Regional Cancer Center
- CCOP - Kansas City
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cotton-O'Neil Cancer Center
- St. Francis Comprehensive Cancer Center
- Lucille P. Markey Cancer Center at University of Kentucky
- James Graham Brown Cancer Center at University of Louisville
- Tulane Cancer Center Office of Clinical Research
- Ochsner Health Center - Bluebonnet
- Ochsner Health Center - Covington
- CCOP - Ochsner
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- York Hospital's Oncology Treatment Center
- DeCesaris Cancer Institute at Anne Arundel Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Veterans Affairs Medical Center - Baltimore
- National Naval Medical Center
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital of Cecil County
- Frederick Memorial Hospital Regional Cancer Therapy Center
- John R. Marsh Cancer Center at Washington County Hospital
- Peninsula Regional Medical Center
- Holy Cross Hospital
- Massachusetts General Hospital
- Dana-Farber/Brigham and Women's Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Boston University Cancer Research Center
- Beth Israel Deaconess Medical Center
- Caritas St. Elizabeth's Medical Center
- Lahey Clinic Medical Center - Burlington
- Lowell General Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
- Newton-Wellesley Hospital
- Caritas Norwood Hospital
- NSMC Cancer Center - Peabody
- Berkshire Hematology Oncology, PC
- Commonwealth Hematology-Oncology, PC - Quincy
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- UMASS Memorial Cancer Center - University Campus
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Clemens Regional Medical Center
- Mercy General Health Partners
- Michiana Hematology Oncology PC - Niles
- Northern Michigan Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- MeritCare Bemidji
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- St. Luke's Hospital Cancer Care Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Immanuel St. Joseph's
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Veterans Affairs Medical Center - Minneapolis
- Humphrey Cancer Center at North Memorial Outpatient Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- University of Mississippi Cancer Clinic
- Keesler Air Force Base Medical Center
- Regional Cancer Center at Singing River Hospital
- Central Care Cancer Center at Carrie J. Babb Cancer Center
- Skaggs Cancer Center at Skaggs Regional Medical Center
- Southeast Cancer Center
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Goldschmidt Cancer Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- Heartland Hematology Oncology Associates, Incorporated
- Veterans Affairs Medical Center - Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Missouri Baptist Cancer Center
- Comprehensive Cancer Care, PC
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Cancer Resource Center - Lincoln
- Callahan Cancer Center at Great Plains Regional Medical Center
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Lakeside Hospital
- Creighton University Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Nevada Cancer Institute
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Norris Cotton Cancer Center at Catholic Medical Center
- Elliot Regional Cancer Center at Elliot Hospital
- Oncology Center at St. Joseph Hospital
- Veterans Affairs Medical Center - East Orange
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- CentraState Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- UMDNJ University Hospital
- Newark Beth Israel Medical Center
- Valley Hospital - Ridgewood
- Somerset Medical Center
- Frederick R. and Betty M. Smith Cancer Treatment Center
- Overlook Hospital
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Veterans Affairs Medical Center - Buffalo
- CCOP - Hematology-Oncology Associates of Central New York
- Falck Cancer Center at Arnot Ogden Medical Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Winthrop University Hospital
- Mount Kisco Medical Group, PC
- Long Island Jewish Medical Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Nalitt Cancer Institute at Staten Island University Hospital
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Faxton Regional Cancer Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Alamance Cancer Center at Alamance Regional Medical Center
- Waverly Hematology Oncology
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Batte Cancer Center at Northeast Medical Center
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- Kinston Medical Specialists
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Rex Cancer Center at Rex Hospital
- Annie Penn Cancer Center
- Nash Hospitals, Incorporated
- Rutherford Hospital
- Iredell Memorial Hospital
- Marion L. Shepard Cancer Center at Beaufort County Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Wake Forest University Comprehensive Cancer Center
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- MeritCare Broadway
- CCOP - MeritCare Hospital
- Roger Maris Cancer Center at MeritCare Hospital
- Altru Cancer Center at Altru Hospital
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Wood County Oncology Center
- Mercy Cancer Center at Mercy Medical Center
- Adena Regional Medical Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Mount Carmel Hospital East
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Zangmeister Center
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- MedCentral - Mansfield Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- Hillcrest Cancer Center at Hillcrest Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Southern Ohio Medical Center Cancer Center
- North Coast Cancer Care, Incorporated
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Cleveland Clinic - Wooster
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Cancer Centers of Southwest Oklahoma, LLC - Lawton
- Cancer Care Associates - Norman
- Oklahoma University Cancer Institute
- Cancer Care Associates - Mercy Campus
- Cancer Care Associates at Troy and Dollie Smith Cancer Center
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Willamette Falls Hospital
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Kaiser Permanente Health Care - Portland
- Knight Cancer Institute at Oregon Health and Science University
- Celilo Cancer Center at Mid-Columbia Medical Center
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Mercy Fitzgerald Hospital
- Doylestown Hospital Cancer Center
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
- Ephrata Cancer Center at Ephrata Community Hospital
- Geisinger Hazleton Cancer Center
- Riddle Memorial Hospital Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Pottstown Memorial Regional Cancer Center
- St. Joseph Medical Center
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Grand View Hospital
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
- Jennersville Regional Hospital
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Apple Hill Medical Center
- Memorial Hospital of Rhode Island
- Kent County Memorial Hospital
- AnMed Cancer Center
- Keyserling Cancer Center at Beaufort Memorial Hospital
- McLeod Regional Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Thompson Cancer Survival Center
- University of Tennessee Cancer Institute - Memphis
- MBCCOP - Meharry Medical College - Nashville
- Harrington Cancer Center
- Seton Shivers Cancer Program at Brackenridge Hospital
- Brooke Army Medical Center
- Baylor University Medical Center - Houston
- Ben Taub General Hospital
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
- Veterans Affairs Medical Center - Houston
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
- Cancer Therapy and Research Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Fredericksburg Oncology, Incorporated
- Virginia Oncology Associates - Hampton
- Lynchburg Hematology-Oncology Clinic
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Virginia Cancer Institute - West End
- Virginia Commonwealth University Massey Cancer Center
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Providence Centralia Hospital
- St. Francis Hospital
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Harrison Poulsbo Hematology and Onocology
- Good Samaritan Cancer Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Rockwood Clinic Cancer Treatment Center
- Evergreen Hematology and Oncology, PS
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- West Virginia University Health Sciences Center - Charleston
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Princeton Community Hospital
- Langlade Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- Mercy Regional Cancer Center
- UW Cancer Center Johnson Creek
- Franciscan Skemp Healthcare - La Crosse Campus
- Gundersen Lutheran Center for Cancer and Blood
- Dean Medical Center - Madison
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Vince Lombardi Cancer Clinic - Marinette
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Marshfield Clinic - Lakeland Center
- D.N. Greenwald Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- St. Nicholas Hospital
- Saint Michael's Hospital Cancer Center
- Green Bay Oncology, Limited - Sturgeon Bay
- Aurora Medical Center
- Vince Lombardi Cancer Clinic - Two Rivers
- Waukesha Memorial Hospital Regional Cancer Center
- Marshfield Clinic - Wausau Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview UW Cancer Center at Riverview Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
- British Columbia Cancer Agency - Centre for the Southern Interior
- British Columbia Cancer Agency - Vancouver Cancer Centre
- CancerCare Manitoba
- Saint John Regional Hospital
- Margaret and Charles Juravinski Cancer Centre
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Grand River Regional Cancer Centre at Grand River Hospital
- London Regional Cancer Program at London Health Sciences Centre
- Southlake Regional Health Centre
- R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
- Ottawa Hospital Regional Cancer Centre - General Campus
- St. Catharines General Hospital at Niagara Health System
- Cancer Care Program at Thunder Bay Regional Health Sciences
- Toronto East General Hospital
- Odette Cancer Centre at Sunnybrook
- St. Michael's Hospital - Toronto
- Princess Margaret Hospital
- Trillium Health Centre - Mississauga Site
- Windsor Regional Cancer Centre at Windsor Regional Hospital
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm A: FOLFOX or FOLFIRI + bevacizumab
Arm B: FOLFOX or FOLFIRI + cetuximab
Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab
Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.
Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.