Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial
- Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in
patients with epidermal growth factor receptor-positive metastatic unresectable
- Compare the objective response (complete and partial response) in patients treated with
- Compare the safety of these regimens in these patients.
- Compare the clinical benefit (complete response, partial response, or stable disease
for at least 18 weeks) in patients treated with these regimens.
- Compare overall survival, time to progression, and time to treatment failure in
patients treated with these regimens.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior
adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of
2 treatment arms.
- Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV
over 2 hours on day 1.
- Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over
1-2 hours on days 1 and 8.
In both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 3 months for 1 year and
then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this
study within 1.5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
Markus M. Borner, MD
University Hospital Inselspital, Berne