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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

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
GroupInterventionDescription
Cetuximab+FOLFOX4cetuximab* 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+FOLFOX4oxaliplatin* 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+FOLFOX45-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+FOLFOX4leucovorin* 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
NameTimeMethod
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
NameTimeMethod
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
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