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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:
ClinicalTrials.gov Identifier:
NCT00061815
First Posted: June 6, 2003
Last Update Posted: April 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Compare the response rates between the two treatment arms. [ Time Frame: Every six weeks ]
  • Compare progression-free survival between the two treatment arms. [ Time Frame: Every six weeks ]
  • Duration of response within each treatment arm. [ Time Frame: Every six weeks ]
  • Time to response within each treatment arm. [ Time Frame: Every six weeks ]
  • Compare the safety profiles between the two treatment arms. [ Time Frame: Every six weeks ]
  • Compare the quality of life (QOL)between the two treatment arms. [ Time Frame: Every six weeks ]
  • Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. [ Time Frame: Every six weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061815


  Show 39 Study Locations
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00061815     History of Changes
Obsolete Identifiers: NCT00065520
Other Study ID Numbers: CA225-014
First Submitted: June 4, 2003
First Posted: June 6, 2003
Last Update Posted: April 12, 2010
Last Verified: April 2010

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
Oxaliplatin
Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs