Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer
About this trial
This is an interventional treatment trial for Recurrent Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed; confirmation may be from either the primary tumor or a metastasis; patients must have wild type KRAS
- Patients must be registered within 28 days of documented disease progression on first line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this progression must have occurred within 90 days after the last dose of bevacizumab; patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and bevacizumab and then had subsequent progression while on fluoropyrimidine and bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events in the first-line setting are not eligible
- Measurable or nonmeasurable disease
- At least 14 days must have elapsed since the last dose of first line chemotherapy and bevacizumab
- Patients must not have received prior treatment with irinotecan (either as adjuvant or metastatic treatment)
- Patients must have no history of prior treatment with cetuximab or other agents targeting VEGF or EGFR (except for bevacizumab)
- Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment; all adverse events related to radiation therapy must be resolved
- Prior surgery is allowed, provided at least 28 days have elapsed since any major surgery and patient has recovered from all effects
- Zubrod performance status 0-2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT must be =< 5 x IULN; these results must be obtained within 28 days prior to registration
- Serum creatinine =< IULN or measured or estimated creatinine clearance >= 60 mL/min
- Patients must not have a history or known presence of brain metastasis
- Patients may be on full dose anticoagulation with warfarin provided that the patient has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained within 28 days prior to registration
- No clinically relevant bleeding diathesis or coagulopathy
- Patients must not have experienced nephrotic range proteinuria from prior bevacizumab therapy; urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment; urine protein and creatinine used in calculating the UPC ratio must be obtained within 28 days prior to registration
- No uncontrolled high blood pressure (BP) (i.e., systolic BP > 150 mm Hg and diastolic BP > 90 mm Hg)
No cardiovascular event within the past 6 months, including any of the following:
- Arterial thrombosis
- Unstable angina
- Myocardial infarction
- Cerebrovascular accident
- Patients must not have New York Heart Association (NYHA) >= Grade 2 congestive heart failure
- Patients must not have unstable symptomatic arrhythmia requiring medication; (patients with chronic, controlled arrhythmias such as atrial fibrillation or paroxysmal supraventricular tachycardia [PSVT] are eligible)
- No clinically significant peripheral vascular disease
- No serious or nonhealing active wound, ulcer, or bone fracture
- No history of gastrointestinal (GI) perforation while on prior bevacizumab
- No significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding) within the past 6 months unless the source of bleeding has been resected
- No known hypersensitivity to bevacizumab or known potential hypersensitivity to cetuximab
- No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of anticancer treatment
- Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
- No other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ
- All patients 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
- At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Sites / Locations
- Saint Edward Mercy Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- City of Hope Medical Center
- Northbay Cancer Center
- Valley Medical Oncology Consultants-Fremont
- Glendale Memorial Hospital and Health Center
- Marin General Hospital
- Saint Rose Hospital
- University of Southern California
- Fremont - Rideout Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons Inc
- Bay Area Tumor Institute CCOP
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- Palchak David MD
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Sutter Roseville Medical Center
- UC Davis Comprehensive Cancer Center
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Tahoe Forest Cancer Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Memorial Hospital Colorado Springs
- 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
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- The Hospital of Central Connecticut
- Bayhealth Medical Center at Kent General
- Lombardi Comprehensive Cancer Center at Georgetown University
- Edna Williams Cancer Center at the Baptist Cancer Institute
- Mayo Clinic in Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Space Coast Cancer Centers-Titusville
- Piedmont Hospital
- Atlanta Regional CCOP
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Well Star Cobb Hospital
- John B Amos Cancer Center
- Atlanta VA Medical Center
- Dekalb Medical Center
- Gwinnett Medical Center
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- South Georgia Medical Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- John H Stroger Jr Hospital of Cook County
- Resurrection Healthcare
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Saint Anthony Memorial Hospital
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Adventist La Grange Memorial Hospital
- Mcdonough District Hospital
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- 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
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Carle Clinic-Urbana Main
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Community Howard Regional Health
- Indiana University Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology-PC Westville
- McFarland Clinic PC-William R Bliss Cancer Center
- Hematology Oncology Associates-Quad Cities
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Covenant Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Hays Medical Center
- Promise Regional Medical Center-Hutchinson
- Cancer Center of Kansas-Independence
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Olathe Cancer Center
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health 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
- Doctors Carrol, Sheth, Raghavan
- Baton Rouge General Medical Center
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Memorial Hospital at Easton - Shore Regional Cancer Center
- Frederick Memorial Hospital
- Sturdy Memorial Hospital
- Boston Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Oakwood Hospital
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Grand Rapids Clinical Oncology Program
- Holland Community Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Mercy Health Partners-Hackley Campus
- Michiana Hematology Oncology PC-Niles
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Marie Yeager Cancer Center
- Lakeland Hospital
- Saint John Macomb-Oakland Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Duluth Clinic CCOP
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- 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
- Mayo Clinic Health Systems-Mankato
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Woodwinds Health Campus
- Singing River Hospital
- Southeast Missouri Hospital
- Veterans Administration
- University of Missouri - Ellis Fischel
- Saint Louis University Hospital
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Mercy Hospital Springfield
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Hematology-Oncology Centers of the Northern Rockies PC
- Billings Clinic
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Good Samaritan Hospital
- Nebraska Cancer Research Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Sparta Cancer Treatment Center
- Virtua West Jersey Hospital Voorhees
- Montefiore Medical Center
- Veterans Affairs Western New York Health Care System-Buffalo
- Finger Lakes Hematology and Oncology
- Adirondack Cancer Center
- Glens Falls Hospital
- Orange Regional Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Margaret R Pardee Memorial Hospital
- Kinston Medical Specialists PA
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Rutherford Hospital
- Bismarck Cancer Center
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Altru Cancer Center
- Akron General Medical Center
- Mary Rutan Hospital
- Toledo Clinic Cancer Centers-Bowling Green
- Mercy Medical Center
- Aultman Health Foundation
- Adena Regional Medical Center
- North Coast Cancer Care-Clyde
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grady Memorial Hospital
- Community Health Partners Regional Medical Center
- Hematology Oncology Center Incorporated
- Fremont Memorial Hospital
- Fairfield Medical Center
- Lima Memorial Hospital
- Mansfield General Hospital-MedCentral Health System
- Marietta Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Knox Community Hospital
- Licking Memorial Hospital
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Fulton County Health Center
- Saint Ann's Hospital
- Genesis HealthCare System
- Bay Area Hospital
- Adventist Medical Center
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Geisinger Medical Center-Cancer Center Hazelton
- Central PA Hematology-Medical Oncology Associates PC
- Riddle Hospital
- Thomas Jefferson University Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Geisinger Medical Group
- Associates In Hematology Oncology PC-Upland
- Geisinger Wyoming Valley
- AnMed Health Hospital
- South Carolina Oncology Associates PA
- Greenville Health System Cancer Institute-Easley
- McLeod Regional Medical Center
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Instutite/Greenville CCOP
- Self Regional Healthcare
- Cancer Centers of the Carolinas-Greer Medical Oncology
- Greenville Health System Cancer Institute-Greer
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Greenville Health System Cancer Institute-Spartanburg
- Rapid City Regional Hospital
- University of Tennessee - Memphis
- The Don and Sybil Harrington Cancer Center
- Scott and White Memorial Hospital
- Fredericksburg Oncology Inc
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Columbia Basin Hematology and Oncology PLLC
- Skagit Valley Hospital
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Wenatchee Valley Medical Center
- West Virginia University Charleston
- Camden-Clark Memorial Hospital
- Midelfort Clinic-Clairemont Campus
- Mayo Clinic Health System Eau Claire Hospital - Luther Campus
- Aurora Cancer Care-Southern Lakes
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Mercy Health System
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Columbia Saint Mary's Hospital - Ozaukee
- Columbia Saint Mary's Water Tower Medical Commons
- Medical Consultants Limited
- Green Bay Oncology - Oconto Falls
- Green Bay Oncology - Sturgeon Bay
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (chemotherapy, cetuximab)
Arm II (chemotherapy, cetuximab, bevacizumab)
Arm III (closed to accrual as of 4/20/2009)
Patients receive single-agent irinotecan hydrochloride IV or FOLFIRI IV. They also receive cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.
Patients receive single-agent irinotecan hydrochloride or FOLFIRI AND cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.
Patients receive single-agent irinotecan hydrochloride or FOLFIRI AND cetuximab as in arm I. Patients also receive a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.