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Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00061815
First received: June 4, 2003
Last updated: April 8, 2010
Last verified: April 2010
History of Changes
  Purpose

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.


Condition Intervention Phase
Colorectal Cancer
 Biological: cetuximab
Drug: oxaliplatin
Drug: leucovorin
Drug: 5-fluorouracil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Compare overall survival in subjects with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-FU, and LV (FOLFOX4) and cetuximab with FOLFOX4 alone. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the response rates between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
  • Compare progression-free survival between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
  • Duration of response within each treatment arm. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
  • Time to response within each treatment arm. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
  • Compare the safety profiles between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: Yes ]
  • Compare the quality of life (QOL)between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]
  • Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. [ Time Frame: Every six weeks ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: March 2003
Study Completion Date: November 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab+FOLFOX4
  • Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion
  • Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion
  • Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes
 Biological: cetuximab
400 mg/m2 IV
Other Name: Erbitux™
Drug: oxaliplatin
85 mg/m2 IV
Other Name: Eloxatin®
Drug: leucovorin
200 mg/m2 IV
Other Name: Wellcovorin®
Drug: 5-fluorouracil
400 mg/m2 IV
Other Name: 5-FU
Drug: 5-fluorouracil
600 mg/m2 IV
Other Name: 5-FU
Biological: cetuximab
250 mg/m2 IV
Other Name: Erbitux™
Active Comparator: FOLFOX4.
  • Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion.
  • Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion.
 Drug: oxaliplatin
85 mg/m2 IV
Other Name: Eloxatin®
Drug: leucovorin
200 mg/m2 IV
Other Name: Wellcovorin®
Drug: 5-fluorouracil
400 mg/m2 IV
Other Name: 5-FU
Drug: 5-fluorouracil
600 mg/m2 IV
Other Name: 5-FU

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented colorectal cancer which is EGFR-positive and is metastatic.
  • Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.

Exclusion Criteria:

  • A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Known metastases in the central nervous system.
  • Symptomatic sensory or peripheral neuropathy.
  • More than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer.
  • Prior oxaliplatin therapy.
  • Prior cetuximab or other therapy which targets the EGF pathway.
  • Prior chimerized or murine monoclonal antibody therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061815

  Hide Study Locations
Locations
United States, Arkansas
ImClone Investigational Site
Little Rock, Arkansas, United States, 72205
ImClone Investigational Site
Springdale, Arkansas, United States, 72764
United States, California
ImClone Investigational Site
Fountain Valley, California, United States, 92708
ImClone Investigational Site
Gilroy, California, United States, 95020
ImClone Investigational Site
Greenbrae, California, United States, 94904
ImClone Investigational Site
Orange, California, United States, 92868
ImClone Investigational Site
Pomona, California, United States, 91767
ImClone Investigational Site
San Diego, California, United States, 92120
ImClone Investigational Site
Vista, California, United States, 92083
United States, Connecticut
ImClone Investigational Site
Hartford, Connecticut, United States, 06105
ImClone Investigational Site
Norwalk, Connecticut, United States, 06856
ImClone Investigational Site
Stamford, Connecticut, United States, 06902
ImClone Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
ImClone Investigational Site
Boynton Beach, Florida, United States, 33435
ImClone Investigational Site
Jacksonville, Florida, United States, 32207
ImClone Investigational Site
Leesburg, Florida, United States, 34748
ImClone Investigational Site
Orlando, Florida, United States, 32804
ImClone Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
ImClone Investigational Site
Atlanta, Georgia, United States, 30309
ImClone Investigational Site
Macon, Georgia, United States, 31201
United States, Kentucky
ImClone Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
ImClone Investigational Site
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
ImClone Investigational Site
Baltimore, Maryland, United States, 21225
ImClone Investigational Site
Clinton, Maryland, United States, 20735
United States, Michigan
ImClone Investigational Site
St. Joseph, Michigan, United States, 49085
United States, Missouri
ImClone Investigational Site
Kansas City, Missouri, United States, 64131
ImClone Investigational Site
Rolla, Missouri, United States, 65401
United States, New Jersey
ImClone Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
ImClone Investigational Site
Armonk, New York, United States, 10504
ImClone Investigational Site
Brooklyn, New York, United States, 11235
ImClone Investigational Site
East Setauket, New York, United States, 11733
United States, North Carolina
ImClone Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
ImClone Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
ImClone Investigational Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
ImClone Investigational Site
Knoxville, Tennessee, United States, 37920
ImClone Investigational Site
Nashville, Tennessee, United States, 37203
United States, Utah
ImClone Investigational Site
Ogden, Utah, United States, 84403
United States, Virginia
ImClone Investigational Site
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00061815     History of Changes
Obsolete Identifiers: NCT00065520
Other Study ID Numbers: CA225-014
Study First Received: June 4, 2003
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Cetuximab
Leucovorin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on May 22, 2013