Phase II trial of erlotinib and capecitabine for patients with previously untreated metastatic colorectal cancer.

Background: This Simon 2-stage phase II trial was designed to document antitumor activity of capecitabine in combination with erlotinib in patients with previously untreated metastatic colorectal cancer (CRC).

Patients And Methods: Time to tumor progression, objective response rate, and time to treatment failure were to be assessed. Secondary objectives included determination of toxicity.