S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring BRAF Mutant, Metastatic
Eligibility Criteria
- STEP I INITIAL REGISTRATION: BRAFV600E TESTING:
- Patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum that is either metastatic, or locally advanced and unresectable
- Patients must have BRAFV600E mutant status documented by a Clinical Laboratory Improvements Amendments (CLIA) certified laboratory on a pathology report prior to Step 2 registration; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory may also be accepted; if a BRAFV600E mutation is known, then the patient must be registered to Step 2 Randomization immediately following Step 1 Initial Registration; if testing has not been performed locally, BRAFV600E testing must be completed by the central lab prior to Step 2 Randomization; if the specimen does not have a BRAFV600E mutation, the patient is ineligible for Step 2 Randomization
- Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 90 days prior to Step 1 Initial Registration; eligible patients should be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to Step 1 Initial Registration
- Patients must have had one or two prior regimens of systemic chemotherapy for metastatic disease; prior treatment with irinotecan is allowed; a maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment; prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
Patients must not have been treated with any of the following prior to Step 2 Randomization:
- Cetuximab, panitumumab, or any other monoclonal antibody against EGFR or inhibitor of EGFR
- BRAF inhibitor including, but not limited to, vemurafenib or dabrafenib; regorafenib is not considered a BRAF inhibitor for the purpose of determining trial eligibility
- Mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor including, but not limited to, trametinib or selumetinib
- Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 14 days prior to Step 1 Initial Registration and all toxicity must be resolved to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to Step 1 Initial Registration
- Patients must not have a tumor with a mutation detected in codons 12 or 13 in KRAS; patients must not have a tumor with a known mutation detected in codons 61, 117, or 146 of KRAS or NRAS
- SPECIMEN SUBMISSION CRITERIA:
- Patients must have tumor (slides or block) available for submission for V600E BRAF testing
- Patients must have additional tumor available and be willing to submit tissue and blood samples
- SPECIMEN SUBMISSION CRITERIA REGULATORY CRITERIA:
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 Initial Registration of patients who have not yet submitted specimens for the central BRAFV600E testing, the appropriate consent form is the Step 1 Consent Form; for both Step 1 Initial Registration and Step 2 Randomization of patients whose BRAF mutation status is already known, the appropriate consent form is the Step 2 Consent Form
- STEP 2 RANDOMIZATION:
- Patients must have BRAFV600E mutation
- Patients must have measurable or non-measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess all disease must have been completed within 28 days prior to Step 2 Randomization; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- Patients must have a Zubrod performance status of 0-1
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,00/mcL
- Hemoglobin >= 9 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (IULN) or =< 5 x IULN if liver metastases are present
- Total bilirubin =< 1.5 x IULN
- Serum creatinine =< 1.5 x IULN within 14 days prior to Step 2 Randomization OR
- Calculated creatinine clearance > 60 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to Step 2 Randomization
- Patients must have an electrocardiogram (ECG) within 14 days prior to Step 2 Randomization
- Patients must have corrected QT (QTc) =< 500 msec
- Patients must not have a known history of Gilbert's Syndrome or known homozygosity for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1)*28 allele
- Patients must not have interstitial pneumonia or extensive symptomatic interstitial fibrosis of the lung
- Patients must not have an uncontrolled intercurrent illness including, but not limited to, active bleeding diathesis, uncontrolled infection/disorders, nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy, or psychiatric illness/social situations which would limit compliance with study requirements
- Patients must be able to swallow pill/tablet and have no refractory nausea, vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
- Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method while on study and for 30 days after study treatment; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years
- STEP 2 RANDOMIZATION REGULATORY CRITERIA:
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients, the appropriate consent form for this registration is the Step 2 Consent Form
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- STEP 3 CROSSOVER REGISTRATION:
- Patients must have documented disease progression while on Arm 1 of this protocol; the follow-up tumor assessment form documenting disease progression must be submitted to Southwestern Oncology Group (SWOG) prior to Step 3
- Registration to Step 3 Crossover must be within 28 days of discontinuation of Arm 1 protocol treatment; patients going off treatment for any other reason are not eligible
- ANC >= 1,500/mcL within 14 days prior to Step 3 registration
- Platelets >= 100,00/mcL within 14 days prior to Step 3 registration
- Hemoglobin >= 9 g/dL within 14 days prior to Step 3 registration
- AST and ALT =< 2.5 x institutional upper limit of normal (IULN) or =< 5 x IULN if liver metastases are present within 14 days prior to Step 3 registration
- Total bilirubin =< 1.5 x IULN within 14 days prior to Step 3 registration
- Serum creatinine =< 1.5 x IULN within 14 days prior to Step 3 registration OR
- Calculated creatinine clearance > 60 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to Step 3 registration
Sites / Locations
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- University of Arizona Cancer Center-Orange Grove Campus
- University of Arizona Cancer Center-North Campus
- The University of Arizona Medical Center-University Campus
- Mercy Cancer Center-Hot Springs
- Fowler Family Center for Cancer Care
- University of Arkansas for Medical Sciences
- Veteran's Administration Medical Center
- Kaiser Permanente-Anaheim
- Kaiser Permanente-Deer Valley Medical Center
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills - Peninsula Hospitals
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente Hospital
- Kaiser Permanente-Fremont
- Kaiser Permanente
- Marin Cancer Care Inc
- Marin General Hospital
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Cadillac
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Keck Medical Center of USC Pasadena
- PCR Oncology
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Riverside
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter General Hospital
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Salinas Valley Memorial
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Marcos
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Kaiser Permanente
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Memorial Hospital Colorado Springs
- Denver Health Medical Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- Mercy Medical Center
- Southwest Oncology PC
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital-Derby Care Center
- Smilow Cancer Hospital Care Center-Fairfield
- Greenwich Hospital
- Medical Oncology and Hematology Group PC-Guilford
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Eastern Connecticut Hematology and Oncology Associates
- Smilow Cancer Hospital-Orange Care Center
- Charlotte Hungerford Hospital Center for Cancer Care
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital-Waterbury Care Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Florida Hospital Cancer Institute Altamonte
- University of Florida
- Florida Hospital Kissimmee
- Mount Sinai Medical Center
- Florida Hospital Orlando
- Florida Urology Associates-Orlando
- UF Cancer Center at Orlando Health
- Florida Hospital East Orlando
- Florida Hospital Cancer Institute Winter Park
- Northside Hospital
- John B Amos Cancer Center
- Memorial University Medical Center
- Summit Cancer Care-Memorial
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Low Country Cancer Care Associates PC
- Hawaii Oncology Inc-Pali Momi
- Pali Momi Medical Center
- The Cancer Center of Hawaii-Leeward
- Hawaii Cancer Care Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Hawaii Oncology Inc-Kuakini
- Kuakini Medical Center
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Center of Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Joliet Oncology-Hematology Associates Limited
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Edward Hospital/Cancer Center?Plainfield
- Illinois CancerCare-Princeton
- North Shore Medical Center
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Reid Health
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- Porter Memorial Hospital
- Mary Greeley Medical Center
- McFarland Clinic PC-William R Bliss Cancer Center
- McFarland Clinic PC-Boone
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- McFarland Clinic PC-Trinity Cancer Center
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Mercy Medical Center - North Iowa
- Story County Medical Center-South Campus
- Siouxland Regional Cancer Center
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Olathe Medical Center
- University of Kansas Cancer Center-Overland Park
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina 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 - Wichita
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Jewish Hospital Medical Center South
- Christus Saint Frances Cabrini Hospital
- LSU Health Baton Rouge-North Clinic
- Louisiana Hematology Oncology Associates LLC
- Medical Oncology LLC
- Mary Bird Cancer Center/Saint Tammany Parish
- Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Union Hospital of Cecil County
- Northwest Hospital Center
- Peninsula Regional Medical Center
- Beverly Hospital
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Baystate Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren-Bay Region
- Henry Ford Cancer Institute¿Downriver
- Great Lakes Cancer Institute
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital-Dearborn
- Henry Ford Medical Center-Fairlane
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Singh and Arora Hematology Oncology PC
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- McLaren-Greater Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Saint Mary Mercy Hospital
- Monroe Cancer Center
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Mercy Health Mercy Campus
- Lakeland Community Hospital
- Assarian Cancer Center
- Henry Ford Medical Center-Columbus
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Providence Hospital-Southfield Cancer Center
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Sanford Clinic North-Bemidgi
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Hattiesburg Clinic - Hematology/Oncology Clinic
- Forrest General Hospital / Cancer Center
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center-Carrie J Babb Cancer Center
- Parkland Health Center-Bonne Terre
- CoxHealth Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Barnes-Jewish West County Hospital
- Capital Region Medical Center-Goldschmidt Cancer Center
- Freeman Health System
- Mercy Hospital-Joplin
- Truman Medical Center
- The University of Kansas Cancer Center-South
- The University of Kansas Cancer Center-North
- The University of Kansas Cancer Center-Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Saint John's Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Siteman Cancer Center - Saint Peters
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Southeast Nebraska Cancer Center
- Faith Regional Medical Offices West
- Great Plains Regional Medical Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Hemotology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Oncology Hematology West
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Creighton University Medical Center
- Midlands Community Hospital
- Regional West Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology - Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology - Fort Apache
- Cancer and Blood Specialists-Fort Apache
- Comprehensive Cancer Centers of Nevada
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- 21st Century Oncology - Vegas Tenaya
- Saint Mary's Regional Medical Center
- Dartmouth Hitchcock Medical Center
- Norris Cotton Cancer Center-Manchester
- Norris Cotton Cancer Center-Nashua
- Englewood Hospital and Medical Center
- Virtua Memorial
- Newark Beth Israel Medical Center
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Sparta Cancer Treatment Center
- Inspira Medical Center Vineland
- Virtua Voorhees
- Valley Health System-Hematology/Oncology
- Inspira Medical Center Woodbury
- University of New Mexico Cancer Center
- Memorial Medical Center - Las Cruces
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls Hospital
- Weill Medical College of Cornell University
- State University of New York Upstate Medical University
- Faxton-Saint Luke's Healthcare
- Randolph Hospital
- Asheville Hematology-Oncology Associates
- Cone Health Cancer Center at Alamance Regional
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Park Ridge Hospital Breast Health Center
- Maria Parham Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Kinston Medical Specialists PA
- Scotland Memorial Hospital-Laurinburg Cancer Center
- Cone Heath Cancer Center at Mebane
- Annie Penn Memorial Hospital
- Johnston Memorial Hospital
- Southeastern Medical Oncology Center-Wilson
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Akron General Medical Center
- Strecker Cancer Center-Belpre
- Mercy Medical Center
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geaugra Hospital
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- University of Cincinnati/Barrett Cancer Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physicians LLC-Samaritan North
- Samaritan North Health Center
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- Southwest General Health Center Ireland Cancer Center
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- Ireland Cancer Center at Firelands Regional Medical Center
- North Coast Cancer Care
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- Flower Hospital
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- South Pointe Hospital
- University Pointe
- Saint Ann's Hospital
- UH-Seidman Cancer Center at Saint John Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Oncology and Hematology Care Southeast
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Doylestown Hospital
- PinnacleHealth Cancer Center-Community Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Phoenixville Hospital
- Geisinger Medical Oncology-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Geisinger Medical Group
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Susquehanna Cancer Center
- Roper Hospital
- Charleston Hematology Oncology Associates-Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Bon Secours Saint Francis Hospital
- Charleston Hematology Oncology Associates PA-St. Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Greenville Health System Cancer Institute-Easley
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Saint Francis Cancer Center
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Greenville Health System Cancer Institute-Seneca
- Greenville Health System Cancer Institute-Spartanburg
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Thompson Cancer Survival Center
- Meharry Medical College
- Memorial GYN Plus
- M D Anderson Cancer Center
- Scott and White Healthcare Round Rock
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont College of Medicine
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Virginia Mason Bainbridge Island Medical Center
- Overlake Hospital Medical Center
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Virginia Mason Federal Way Medical Center
- Saint Francis Hospital
- Tacoma/Valley Radiation Oncology Centers-Gig Harbor
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Northwest Cancer Clinic
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Virginia Mason Lynnwood Medical Center
- Skagit Valley Hospital Regional Cancer Care Center
- Skagit Valley Hospital
- Olympic Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Peninsula Cancer Center
- MultiCare Good Samaritan Hospital
- Tacoma/Valley Radiation Oncology Centers-Puyallup
- Virginia Mason Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Seattle Cancer Care Alliance
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- University of Washington Medical Center
- Olympic Medical Cancer Care Center
- Providence Regional Cancer System-Shelton
- Rockwood Clinic Cancer Treatment Center-Valley
- Cancer Care Northwest - Spokane South
- Rockwood Cancer Treatment Center-DHEC-Downtown
- Spokane Valley Cancer Center-Mayfair
- Cancer Care Northwest-Valley
- Cancer Care Northwest-North Spokane
- Tacoma/Valley Radiation Oncology Centers-Jackson Hall
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Tacoma/Valley Radiation Oncology Centers-Saint Joe's
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- West Virginia University Charleston
- Langlade Hospital and Cancer Center
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Holy Family Memorial Hospital
- Marshfield Clinic
- Wheaton Franciscan Healthcare - Saint Joseph
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic-Rice Lake Center
- HSHS Saint Nicholas Hospital
- Marshfield Clinic Cancer Care at Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Marshfield Clinic - Weston Center
- Aspirus UW Cancer Center
- Marshfield Clinic - Wisconsin Rapids Center
- Cheyenne Regional Medical Center-West
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (cetuximab, irinotecan hydrochloride)
Arm II (cetuximab, irinotecan hydrochloride, vemurafenib)
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.
Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.