Phase II study of docetaxel plus cisplatin as a second-line combined therapy in patients with advanced gastric carcinoma

Background: We conducted a pilot phase II study to evaluate the efficacy and safety of docetaxel and cisplatin as a combination second-line therapy for advanced gastric cancer. Patients and Methods: Between 2000 and 2003, 30 patients were enrolled into this study. Chemotherapy consisted of 60 mg/m(2) of docetaxel followed by 60 mg/m(2) of cisplatin. This regimen was repeated at least three times at 3-week intervals. Results: The overall response rate was 26.7%. The median time to disease progression was 4.5 months. The median survival time was 13 months from the start of the first-line therapy and 6 months from the second-line therapy. With respect to toxicity, the major adverse effect was leukopenia, which reached grades 3-4 in 26.7%. Non-hematological toxicities were usually moderate, and no deaths were attributable to the adverse effects of the drugs. Conclusion: This combination therapy was effective as a second-line treatment for advanced gastric cancer with acceptable toxic side-effects.