Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer

NCT00056030 | Completed Phase 2

• 3 other identifiers: NCCTG-N014ANCI-2012-02521CDR0000271923
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 162

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.

Conditions

Colorectal Cancer; Metastatic Cancer

Keywords

liver metastases; stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• Surgical resectability rate as assessed by surgical resection of liver metastases

  Up to 4 years

Secondary Outcomes (3)

• Response rate as measured by RECIST criteria every 6 weeks

  Up to 4 years

• Overall survival

  Up to 4 years

• Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks

  Up to 4 years

Study Arms (1)

cetuximab + oxaliplatin + leucovorin + fluorouracil

EXPERIMENTAL

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.

Biological: cetuximab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin

Interventions

cetuximab BIOLOGICAL

cetuximab + oxaliplatin + leucovorin + fluorouracil

fluorouracil DRUG

cetuximab + oxaliplatin + leucovorin + fluorouracil

leucovorin calcium DRUG

cetuximab + oxaliplatin + leucovorin + fluorouracil

oxaliplatin DRUG

cetuximab + oxaliplatin + leucovorin + fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (162)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Trinity Medical Center - East

Moline, Illinois, 61265, United States

Location

Unknown Facility

Moline, Illinois, 61265, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Unknown Facility

Bettendorf, Iowa, 52722, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

Dickinson County Healthcare System

Iron Mountain, Michigan, 49801, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, 48144, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital - Monroe

Monroe, Michigan, 48162, United States

Location

Unknown Facility

Alexandria, Minnesota, 56308, United States

Location

MeritCare Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota, 55805-1983, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller - Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Unknown Facility

Fergus Falls, Minnesota, 56537, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Lichfield, Minnesota, 55355, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Chippewa County - Montevideo Hospital and Medical Center

Montevideo, Minnesota, 56265, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

HealthEast Cancer Care at St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

HealthEast Cancer Care at Woodwinds Health Campus

Woodbury, Minnesota, 55125, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405-5309, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Broadway

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Guthrie Cancer Center at Guthrie Clinic Sayre

Sayre, Pennsylvania, 18840, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, 22401, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Steven R. Alberts, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: December 1, 2004
• Primary Completion: October 1, 2007
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (162)