A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
- Compare survival of patients with metastatic epidermal growth factor receptor-positive
colorectal cancer treated with cetuximab and best supportive care vs best supportive
- Compare the time to disease progression in patients treated with these regimens.
- Compare the objective response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the health utilities of patients treated with these regimens.
- Conduct a comparative economic evaluation in patients treated with these regimens.
- Determine the safety profile of cetuximab in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center and ECOG performance status (0 or 1 vs 2). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive an initial loading dose of cetuximab 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 hospitalization for end-of-life care).
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 20 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Derek Jonker, MD
Ottawa Regional Cancer Centre
United States: Federal Government