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Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 6, 2003   Last Updated: April 14, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00056030
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Biological: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Surgical resectability rate as assessed by surgical resection of liver metastases [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate as measured by RECIST criteria every 6 weeks [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: December 2004
Estimated Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab.
  • Determine the response rate and overall survival of patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056030

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Moline, Illinois, United States, 61265
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Trinity Medical Center - East
Moline, Illinois, United States, 61265
United States, Indiana
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Bettendorf, Iowa, United States, 52722
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Chippewa County - Montevideo Hospital and Medical Center
Montevideo, Minnesota, United States, 56265
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fergus Falls, Minnesota, United States, 56537
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
United Hospital
St. Paul, Minnesota, United States, 55102
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Alexandria, Minnesota, United States, 56308
Fergus Falls, Minnesota, United States, 56537
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
MeritCare Broadway
Fargo, North Dakota, United States, 58122
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45429
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Pennsylvania
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Steven R. Alberts, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000271923, NCCTG-N014A
Study First Received: March 6, 2003
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00056030     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
liver metastases
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Leucovorin
Rectal Diseases
Neoplastic Processes
Oxaliplatin
Neoplasms by Site
Pathologic Processes
Vitamins
Therapeutic Uses
Neoplasm Metastasis
Micronutrients
Vitamin B Complex
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Cetuximab
Intestinal Diseases
Immunosuppressive Agents
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on November 22, 2009