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

Lilly

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: 5-fluorouracil; Biological: cetuximab; Drug: oxaliplatin; Drug: leucovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00061815

CA225-014

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Cetuximab+FOLFOX4

Experimental group

Description:

* 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

Treatment:

Drug: leucovorin

Drug: oxaliplatin

Biological: cetuximab

Biological: cetuximab

Drug: 5-fluorouracil

Drug: 5-fluorouracil

FOLFOX4.

Active Comparator group

Description:

* 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.

Treatment:

Drug: leucovorin

Drug: oxaliplatin

Drug: 5-fluorouracil

Drug: 5-fluorouracil