Conditions: Colon Cancer Rectal Cancer
Keywords: Tumors Antibodies, Monoclonal Colorectal Neoplasms Metastatic K-RAS Wild-Type Carcinoma of the Colon or Rectum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).

Detailed description:
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants with metastatic Kirsten Rat Sarcoma (K-RAS) wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing regimen.

Arms:
arm 1: Participants in Treatment Group 1 will receive intravenous infusions of Cetuximab 500 milligrams per square meter (mg/m²) and Irinotecan 180 mg/m². arm 2: Participants in Treatment Group 2 will receive intravenous infusions of Cetuximab 500 mg/m², IMC-A12 10 milligrams/kilogram (mg/kg) and Irinotecan 180 mg/m².

Interventions: intervention 1: Cetuximab intervention 2: Irinotecan intervention 3: IMC-A12 (cixutumumab)
Intervention descriptions: intervention 1: Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance intervention 2: 180 mg/m² every 14 days until disease progression or participant intolerance intervention 3: IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance

Protocol document: