Randomized phase II study (GATE study) of docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer

4018 Background: Docetaxel plus cisplatin and fluorouracil (TCF) improved time to progression and survival compared with CF in advanced gastric cancer (GC). We conducted a randomized phase II study of T plus oxaliplatin (E) with or without fluorouracil (F) or capecitabine (X) in advanced GC. Methods: The GATE study is a multinational, randomized, 3-parallel-arm, stratified study. Optimal doses for all regimens were determined in a pilot phase. Patients ≥18 of age, with a KPS >70 and histologically proven metastatic or locally advanced GC not treated with chemotherapy for advanced GC were randomized to TEF (T 50 mg/m² followed by E 85 mg/m² simultaneously with folinic acid 400 mg/m² followed by F 2400 mg/m² as a 46-hr continuous infusion on Day 1, q2w), TE (T 75 mg/m² followed by E 130 mg/m² on Day 1 q3w), and TEX (T 50 mg/m² followed by E 100 mg/m² Day 1, q3w and X 625 mg/m² BID continuously). The primary objective was time to progression (TTP) in the evaluable population; secondary objectives included re...