Conditions: Metastatic Colorectal Cancer
Keywords: Antibodies, Monoclonal Colorectal Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

Detailed description:
The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Arms:
arm 1: Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)

Interventions: intervention 1: IMC-11F8 (necitumumab) intervention 2: Oxaliplatin intervention 3: Folinic acid (FA) intervention 4: 5-FU
Intervention descriptions: intervention 1: IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 intervention 2: Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 intervention 3: FA 400 mg/m² IV infusion bolus injection intervention 4: 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

Protocol document: