A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer

Interventions: FOLFIRI plus ramucirumab treatment ramucirumab : administered intravenously at a dose of 8 mg/kg over 60 minutes on day 1. l-leucovorin: administered intravenously at a dose of 200 mg/m2 over 120 minutes on day 1. irinotecan: administered intravenously at a dose of 150 mg/m2 over 90 minutes on day 1. bolus 5-fluorouracil: administered by rapid intravenous infusion at a dose of 400 mg/m2 on day 1. infusional 5-fluorouracil: administered by continuous intravenous infusion at a dose of 2400 mg/m2 over 46 hours from days 1 to 3.
Primary outcome(s): progression-free survival (PFS)
Study Design: Single arm Non-randomized