Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

Interventions: This is a randomised, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomised to 1 of 2 treatment arms.
Arm I: Patients receive an initial loading dose of cetuximab (Erbitux) IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible.
Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalisation for end of life care). Patients are followed up every 4 weeks.
Primary outcome(s): Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.[Measured from enrolment]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy