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- Title
Phase II clinical trial of SKI-2053R, a new platinum analog, in the treatment of patients with advanced gastric adenocarcinoma.
- Authors
Kim, Noe K.; Im, Seock-Ah; Kim, Dong-Wan; Lee, Moon H.; Jung, Chul W.; Cho, Eun K.; Lee, Jong T.; Ahn, Jin S.; Heo, Dae S.; Bang, Yung-Jue; Kim, N K; Im, S A; Kim, D W; Lee, M H; Jung, C W; Cho, E K; Lee, J T; Ahn, J S; Heo, D S; Bang, Y J
- Abstract
<bold>Background: </bold>SKI-2053R (SK Chemicals, Kyungki-Do, South Korea) is a new platinum derivative with antitumor activity against various cell lines, including cisplatin-resistant tumor cell lines. Preclinical studies have suggested that it is less nephrotoxic than cisplatin. This study evaluated the efficacy and toxicity of SKI-2053R in the treatment of patients with advanced gastric adenocarcinoma.<bold>Methods: </bold>Thirty-seven patients with advanced gastric adenocarcinoma that was unresectable or metastatic were treated. No prior chemotherapy or radiotherapy was allowed. Patients received SKI-2053R 360 mg/m(2) by 1-hour infusion on Day 1. After the first cycle, subsequent doses were adjusted according to the toxicity. Courses were repeated every 28 days.<bold>Results: </bold>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 response 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 toxicity. The most frequent toxicity was Grade 1 or 2 proteinuria (26% of cycles), but it was mild and transient. Leukopenia, thrombocytopenia, azotemia, nausea and vomiting, and neurotoxicity were not frequent. These low toxicity profiles indicated that the dose of SKI-2053R could be increased in future studies.<bold>Conclusions: </bold>SKI-2053R was active in the treatment of patients with gastric adenocarcinoma and had favorable toxicity profiles.
- Publication
Cancer (0008543X), 1999, Vol 86, Issue 7, p1109
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/(SICI)1097-0142(19991001)86:7<1109::AID-CNCR3>3.0.CO;2-G