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

Completed · Phase 3

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00061815

Run by

Eli Lilly and Company

People needed

102

Starts

2003-03-01

Expected to finish

2005-11-01

Last updated by the study team

2010-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• ImClone Investigational Site — Little Rock, Arkansas, United States
• ImClone Investigational Site — Springdale, Arkansas, United States
• ImClone Investigational Site — Fountain Valley, California, United States
• ImClone Investigational Site — Gilroy, California, United States
• ImClone Investigational Site — Greenbrae, California, United States
• ImClone Investigational Site — Orange, California, United States
• ImClone Investigational Site — Pomona, California, United States
• ImClone Investigational Site — San Diego, California, United States
• ImClone Investigational Site — Vista, California, United States
• ImClone Investigational Site — Hartford, Connecticut, United States
• ImClone Investigational Site — Norwalk, Connecticut, United States
• ImClone Investigational Site — Stamford, Connecticut, United States
• ImClone Investigational Site — Waterbury, Connecticut, United States
• ImClone Investigational Site — Boynton Beach, Florida, United States
• ImClone Investigational Site — Jacksonville, Florida, United States
• ImClone Investigational Site — Leesburg, Florida, United States
• ImClone Investigational Site — Orlando, Florida, United States
• ImClone Investigational Site — Tampa, Florida, United States
• ImClone Investigational Site — Atlanta, Georgia, United States
• ImClone Investigational Site — Macon, Georgia, United States
• ImClone Investigational Site — Louisville, Kentucky, United States
• ImClone Investigational Site — Baton Rouge, Louisiana, United States
• ImClone Investigational Site — Baltimore, Maryland, United States
• ImClone Investigational Site — Clinton, Maryland, United States
• ImClone Investigational Site — Saint Joseph, Michigan, United States

Full record on ClinicalTrials.gov

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