Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
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
1 other identifier
interventional
102
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Mar 2003
Shorter than P25 for phase_3 colorectal-cancer
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 4, 2003
CompletedFirst Posted
Study publicly available on registry
June 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedApril 12, 2010
April 1, 2010
1.8 years
June 4, 2003
April 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Every six weeks
Secondary Outcomes (7)
Compare the response rates between the two treatment arms.
Every six weeks
Compare progression-free survival between the two treatment arms.
Every six weeks
Duration of response within each treatment arm.
Every six weeks
Time to response within each treatment arm.
Every six weeks
Compare the safety profiles between the two treatment arms.
Every six weeks
- +2 more secondary outcomes
Study Arms (2)
Cetuximab+FOLFOX4
EXPERIMENTAL* 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
FOLFOX4.
ACTIVE COMPARATOR* 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Bristol-Myers Squibbcollaborator
Study Sites (39)
ImClone Investigational Site
Little Rock, Arkansas, 72205, United States
ImClone Investigational Site
Springdale, Arkansas, 72764, United States
ImClone Investigational Site
Fountain Valley, California, 92708, United States
ImClone Investigational Site
Gilroy, California, 95020, United States
ImClone Investigational Site
Greenbrae, California, 94904, United States
ImClone Investigational Site
Orange, California, 92868, United States
ImClone Investigational Site
Pomona, California, 91767, United States
ImClone Investigational Site
San Diego, California, 92120, United States
ImClone Investigational Site
Vista, California, 92083, United States
ImClone Investigational Site
Hartford, Connecticut, 06105, United States
ImClone Investigational Site
Norwalk, Connecticut, 06856, United States
ImClone Investigational Site
Stamford, Connecticut, 06902, United States
ImClone Investigational Site
Waterbury, Connecticut, 06708, United States
ImClone Investigational Site
Boynton Beach, Florida, 33435, United States
ImClone Investigational Site
Jacksonville, Florida, 32207, United States
ImClone Investigational Site
Leesburg, Florida, 34748, United States
ImClone Investigational Site
Orlando, Florida, 32804, United States
ImClone Investigational Site
Tampa, Florida, 33613, United States
ImClone Investigational Site
Atlanta, Georgia, 30309, United States
ImClone Investigational Site
Macon, Georgia, 31201, United States
ImClone Investigational Site
Louisville, Kentucky, 40202, United States
ImClone Investigational Site
Baton Rouge, Louisiana, 70809, United States
ImClone Investigational Site
Baltimore, Maryland, 21225, United States
ImClone Investigational Site
Clinton, Maryland, 20735, United States
ImClone Investigational Site
Saint Joseph, Michigan, 49085, United States
ImClone Investigational Site
Kansas City, Missouri, 64131, United States
ImClone Investigational Site
Rolla, Missouri, 65401, United States
ImClone Investigational Site
Hackensack, New Jersey, 07601, United States
ImClone Investigational Site
Armonk, New York, 10504, United States
ImClone Investigational Site
Brooklyn, New York, 11235, United States
ImClone Investigational Site
East Setauket, New York, 11733, United States
ImClone Investigational Site
Winston-Salem, North Carolina, 27103, United States
ImClone Investigational Site
Bismarck, North Dakota, 58501, United States
ImClone Investigational Site
Philadelphia, Pennsylvania, 19107, United States
ImClone Investigational Site
Charleston, South Carolina, 29406, United States
ImClone Investigational Site
Knoxville, Tennessee, 37920, United States
ImClone Investigational Site
Nashville, Tennessee, 37203, United States
ImClone Investigational Site
Ogden, Utah, 84403, United States
ImClone Investigational Site
Richmond, Virginia, 23230, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
E-mail: ClinicalTrials@ ImClone.com
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2003
First Posted
June 6, 2003
Study Start
March 1, 2003
Primary Completion
December 1, 2004
Study Completion
November 1, 2005
Last Updated
April 12, 2010
Record last verified: 2010-04