Docetaxel and cisplatin in patients with advanced gastric cancer: results of Japanese phase I/II study.

Two phase II monotherapy studies of docetaxel in patients with advanced gastric cancer were performed in Japan. In group A, docetaxel showed an overall response rate of 23.7% (14/59) in 59 patients, and the adverse reactions were tolerable. In group B, this agent showed the same response rate, of 23.7% (14/59) and the same adverse reaction profile. We then conducted the phase II studies of docetaxel and cisplatin for advanced gastric cancer. A Japanese phase I study in patients with advanced gastric cancer established that docetaxel 60 mg/m2 could be given together with cisplatin 80 mg/m2 without any dose-limiting toxicity. In a phase II trial of this combination regimen in 25 evaluable patients with advanced or recurrent disease, the overall response rate was 28% (7/25), and the response rate for liver metastases was 40% (6/15). Hematological and nonhematological toxicities were acceptable. It is concluded that this regimen is feasible and might warrant further investigation in respect to its relatively high response rate for liver metastases.