Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: History of completely resected primary adenocarcinoma of the colon or rectum No gross or microscopic evidence of residual disease Liver metastases, meeting 1 of the following criteria: Not optimally resectable Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava Includes the main right or main left portal vein and the main hepatic vein of the opposite lobe Requires more than a right or left trisegmentectomy At least 6 metastatic lesions distributed diffusely in both lobes of the liver Measurable disease At least 1 measurable lesion ≥ 20 mm No evidence of extrahepatic metastases by physical examination or x-ray No previously resected extrahepatic metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ ULN No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that would preclude surgical resection of metastases Renal Creatinine ≤ 1.5 times ULN Cardiovascular No myocardial infarction within the past 6 months No clinical evidence of congestive heart failure No New York Heart Association class III-IV heart disease No significant cardiac disease No uncontrolled hypertension No unstable angina No congestive heart failure No uncontrolled arrhythmias Gastrointestinal Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day No severe anorexia or frequent nausea and/or vomiting No history of gastrointestinal bleeding that has not been appropriately addressed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to tolerate major surgery No prior allergic reaction or known sensitivity to chimerized or murine monoclonal antibody therapy No documented presence of human anti-mouse antibodies No known allergy to other platinum compounds No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ, or tumors associated with less than 10% probability of death within 5 years of diagnosis No preexisting neuropathy ≥ grade 2 No symptomatic pulmonary fibrosis or interstitial pneumonitis No uncontrolled bacterial or viral infection HIV negative No fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy No colony-stimulating factors within 24 hours of day 1 of each course No concurrent immunotherapy Chemotherapy At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole or with or without leucovorin calcium No prior oxaliplatin No prior systemic chemotherapy for metastatic disease No prior chemoembolization for metastatic disease No prior hepatic artery infusion chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy At least 12 months since prior adjuvant radiotherapy Prior radiofrequency ablation allowed No prior radiotherapy to the liver No prior radiotherapy to more than 25% of the bone marrow No concurrent radiotherapy Surgery See Disease Characteristics More than 21 days since prior abdominal exploration (with or without intestinal resection) Other No prior anti-EGFR-directed therapy Prior cryotherapy allowed No oral cryotherapy on day 1 of each course
Sites / Locations
- Mobile Infirmary Medical Center
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- Trinity Medical Center - East
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- 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
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Green Bay Oncology, Limited - Escanaba
- Dickinson County Healthcare System
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- 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
- Chippewa County - Montevideo Hospital and Medical Center
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- St. Francis Cancer Center at St. Francis Medical Center
- HealthEast Cancer Care at St. Joseph's Hospital
- CentraCare Clinic - River Campus
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Big Sky Oncology
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Rutherford Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Altru Cancer Center at Altru Hospital
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- 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
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Medical Center
- Allegheny Cancer Center at Allegheny General Hospital
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Fredericksburg Oncology, Incorporated
- 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
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
Arms of the Study
Arm 1
Experimental
cetuximab + oxaliplatin + leucovorin + fluorouracil
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.