Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer
Phase 3
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00061815
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cetuximab+FOLFOX4 cetuximab * 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+FOLFOX4 oxaliplatin * 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+FOLFOX4 5-fluorouracil * 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+FOLFOX4 leucovorin * 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. leucovorin * 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. FOLFOX4. oxaliplatin * 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. FOLFOX4. 5-fluorouracil * 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Compare the quality of life (QOL)between the two treatment arms. Every six weeks Conduct an economic assessment comparing healthcare resource utilization between the two treatment arms. Every six weeks
Trial Locations
- Locations (1)
ImClone Investigational Site
🇺🇸Richmond, Virginia, United States
ImClone Investigational Site🇺🇸Richmond, Virginia, United States