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Low-dose docetaxel and cisplatin combination chemotherapy for stage II/III gastric cancer showing resistance to S-1 adjuvant chemotherapy: a phase I study

Abstract To establish a safe, long-term regimen of docetaxel (DOC) and cisplatin (CDDP) in an outpatient setting for gastric cancer refractory to S-1 adjuvant chemotherapy, a dose-escalating phase I study was conducted. Cohorts of patients were treated with escalating doses of DOC (starting at 20 mg/m2 per week with 5 mg/m2 increments) and a fixed dose of CDDP (25 mg/m2). Drugs were administered on days 1, 8, and 15. A cycle of this treatment was 28 days. In total, 52 courses were performed, and the mean number of courses was 5·3. Two of the four patients at dose level 3 showed dose-limiting toxicities (grade 4 neutropenia, and grade 3 anorexia and dehydration). The recommended dose (RD) of DOC was therefore defined as 25 mg/m2. There is a need for a phase II clinical trial using this regimen in patients with S-1-refractory stage II/III gastric cancer.