Phase I study of short-time oxaliplatin, capecitabine and epirubicin (EXE) as first line therapy in patients with non-resectable gastric cancer

Abstract

A phase I trial of short-time oxaliplatin (E), capecitabine (X) and epirubicin (E) for patients with metastatic gastric cancer was initiated to establish the recommended dose for further therapy with short-time EXE. Patients received out-patient therapy with a fixed dose of epirubicin 50 mg/m² day 1; escalating doses of capecitabine (1 000 to 1 250 mg/m²/day continuously) and escalating doses of oxaliplatin (85 to 130 mg/m² day 1 as a 30 minutes infusion). Cycles were repeated every 21 days for a maximum of 8 cycles. From June 2003 to June 2004, 31 patients were treated. Median age was 61 years (39–75 years), and median performance status was 0 (0–2). At level 3, one of six patients developed DLT and at dose level 4, two of six patients developed DLT (both patients had grade 4 hematological toxicities) and thus further dose escalation was not attempted. Median number of cycles was 6 (1–8), median survival was 9.2 months and median TTP was 7.5 months. A combination of epirubicin 50 mg/m² day 1, capecitabine 1 000 mg/m² continuously and oxaliplatin 130 mg/m² day 1 each 3 weeks is an easily administered and well tolerated out-patient regimen for patients with non-resectable gastric cancer.