Multicenter phase II study of pemetrexed and oxaliplatin as first-line therapy in advanced gastric cancer

14045 Background: We have previously reported that single-agent pemetrexed is active in metastatic gastric cancer. On the basis of the potential synergism of pemetrexed and oxaliplatin, we explored the combination in patients with locally advanced/metastatic gastric carcinoma. Methods: The primary objective was activity of the combination. Eligible patients had to ≥1 measurable lesion according to RECIST. Pemetrexed 500 mg/m2 was given intravenously over 10 minutes, and oxaliplatin 120 mg/m2 was given over 2 hours; both drugs were given on day 1 of a 21-day cycle. Patients were to receive ≥6 (maximum of 8) cycles unless disease progression occurred. Vitamin supplementation was given as well as dexamethasone. A total of 43 patients were planned in a two-stage design with 13 patients in the first stage. An interim analysis was planned at the end of the first stage, so the trial could be stopped if ≤3 responses were observed. Results: Between May 2004 and January 2005, 13 patients (6 females) entered the stu...