FOLFIRI Plus Bevacizumab 5 mg/kg Versus 10 mg/kg as Second-line Therapy in Patients with Metastatic Colorectal Cancer Who Have Failed First-line Bevacizumab Plus Oxaliplatin-based Therapy: A Randomized Phase III Study (EAGLE Study)

We planned a multicenter randomized phase III study to evaluate the efficacy of appropriate dose of bevacizumab (5 or 10 mg/kg) with FOLFIRI in patients with advanced/metastatic colorectal cancer who have failed prior bevacizumab plus oxaliplatin-based therapy. The primary endpoint is progression-free survival. The secondary endpoints are the toxicity, response rate, time to treatment failure, overall survival, overall survival from the start of the first-line treatment and second progression-free survival (time duration from the initiation of the first-line treatment until progression after the protocol treatment). A total of 370 patients were considered to be appropriate for this trial.