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

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Authors
Kim, Noe Kyeong; Im, Seock-Ah; Kim, Dong-Wan; Lee, Moon H.; Jung, Chul W.; Cho, Eun K.; Lee, Jong T.; Ahn, Jin S.; Heo, Dae Seog; Bang, Yung-Jue
Issue Date
1999-10
Citation
Cancer, Vol.86 No.7, pp.1109-1115
Keywords
SKI-2053Rgastric carcinomachemotherapyclinical trialPhase II study
Abstract
BACKGROUND. SKI-2053 R (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. METHODS. 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. 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 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. 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.
ISSN
0008-543X
URI
http://hdl.handle.net/10371/165584
DOI
https://doi.org/10.1002/(SICI)1097-0142(19991001)86:7<1109::AID-CNCR3>3.0.CO;2-G
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
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