A novel combination of cisplatin, irinotecan, and capecitabine in patients with advanced cancer

Abstract

Background: We conducted a dose escalation study combining cisplatin, irinotecan, and capecitabine (CIC), aiming to establish the maximum tolerated doses (MTD), side effect profile, and dose-limiting toxicity (DLT) of this novel regimen. Patients and methods: Intravenous cisplatin and irinotecan were to be administered on days 1 and 8, and oral capecitabine on days 1-14 of a 3-week cycle. The study was conducted in three parts. Part A: escalating doses of irinotecan (40 → 80 mg/m2) and capecitabine (1000 → 3300 mg/d) combined with a fixed dose of cisplatin (30 mg/m2). Part B: escalating doses of irinotecan (MTD-A → MTD-A + 40 mg/m2) with fixed doses of cisplatin (20 mg/m2) and capecitabine (..