Phase II clinical trial of SKI-2053R, a new platinum analog, in the treatment of patients with advanced gastric adenocarcinoma

BACKGROUND. SKI-2053 R (SK Chemicals; Kyungki-Do, South Korea) is a new pla tinum derivative with antitumor activity against various cell lines, includ ing cisplatin-resistant tumor cell lines. Preclinical studies have suggeste d that it is less nephrotoxic than cisplatin. This study evaluated the effi cacy and toxicity of SKI-2053R in the treatment of patients with advanced g astric adenocarcinoma. METHODS. Thirty-seven patients with advanced gastric adenocarcinoma that wa s unresectable or metastatic were treated. No prior chemotherapy or radioth erapy was allowed. Patients received SKI-2053R 360 mg/m(2) by 1-hour infusi on on Day. After the first cycle, subsequent doses were adjusted according to the toxicity. Courses were repeated every 28 days. RESULTS. Thirty-five patients were evaluable for response and toxicity. Six patients achieved a major response (17%; 95% confidence interval, 8-33%); 2 were complete and 4 were partial responses. The median duration of respon se was 7.2 months, with a range of 1-20 months. Patients could tolerate the treatment without significant toxicity. No patients had Grade 3 or 4 toxic ity. The most frequent toxicity was Grade 1 or 2 proteinuria (26% of cycles ), but it was mild and transient. Leukopenia, thrombocytopenia, azotemia, n ausea and vomiting, and neurotoxicity were not frequent. These low toxicity profiles indicated that the dose of SKI-2053R could be increased in future studies. CONCLUSIONS. SKI-2053R was active in the treatment of patients with gastric adenocarcinoma and had favorable toxicity profiles. Cancel 1999;86:1109-15 . (C) 1999 American Cancer Society.