Brivanib and Cetuximab versus Cetuximab and Placebo in treating patients with metastatic colorectal cancer who have been previously treated with combination chemotherapy

Interventions: This ia a randomised, double-blind, multicentre study. Patients will be stratified by centre and ECOG (Eastern Cooperative Oncology Group) perfomance status (ie: 0 or 1 versus 2) into one of two treatment arms.
Arm I: Patients will receive Brivanib 800mg orally daily, in addition to an initial loading dose infusion of Cetuximab (Erbitux) 400mg/m2 over 120 minutes. Thereafter, patients will receive weekly maintenance infusions of Cetuximab 250mg/m2 over 60 minutes.
Arm II: Patients will receive placebo orally daily, and an initial loading dose of Cetuximab 400mg/m2 IV over 120 minutes. Thereafter, the patients will receive a weekly maintenance infusion of Cetuximab 250mg/m2 IV over 60 minutes.
Primary outcome(s): To compare the overall survival of patients with previously treated metastatic colorectal cancer treated with Brivanib in combination with Cetuximab with those treated with placebo and Cetuximab[At interim analysis point (ie: > 263 deaths) and end of study]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy