Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
NCT ID: NCT00061815
Last Updated: 2010-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2003-03-31
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
cetuximab
400 mg/m2 IV
oxaliplatin
85 mg/m2 IV
leucovorin
200 mg/m2 IV
5-fluorouracil
400 mg/m2 IV
5-fluorouracil
600 mg/m2 IV
cetuximab
250 mg/m2 IV
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.
oxaliplatin
85 mg/m2 IV
leucovorin
200 mg/m2 IV
5-fluorouracil
400 mg/m2 IV
5-fluorouracil
600 mg/m2 IV
Interventions
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cetuximab
400 mg/m2 IV
oxaliplatin
85 mg/m2 IV
leucovorin
200 mg/m2 IV
5-fluorouracil
400 mg/m2 IV
5-fluorouracil
600 mg/m2 IV
cetuximab
250 mg/m2 IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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ImClone LLC
Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
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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
ImClone Investigational Site
Kansas City, Missouri, United States
ImClone Investigational Site
Rolla, Missouri, United States
ImClone Investigational Site
Hackensack, New Jersey, United States
ImClone Investigational Site
Armonk, New York, United States
ImClone Investigational Site
Brooklyn, New York, United States
ImClone Investigational Site
East Setauket, New York, United States
ImClone Investigational Site
Winston-Salem, North Carolina, United States
ImClone Investigational Site
Bismarck, North Dakota, United States
ImClone Investigational Site
Philadelphia, Pennsylvania, United States
ImClone Investigational Site
Charleston, South Carolina, United States
ImClone Investigational Site
Knoxville, Tennessee, United States
ImClone Investigational Site
Nashville, Tennessee, United States
ImClone Investigational Site
Ogden, Utah, United States
ImClone Investigational Site
Richmond, Virginia, United States
Countries
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Other Identifiers
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CA225-014
Identifier Type: -
Identifier Source: org_study_id
NCT00065520
Identifier Type: -
Identifier Source: nct_alias
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