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

Abstract

BACKGROUND:

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.

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 1. 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.

• Authors: N K Kim, S A Im, D W Kim, M H Lee, C W Jung, E K Cho, J T Lee, J S Ahn, D S Heo, Y J Bang
• Journal: Cancer (Cancer) Vol. 86 Issue 7 Pg. 1109-15 (Oct 01 1999) ISSN: 0008-543X [Print] United States
• PMID: 10506693 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 1999 American Cancer Society.

Chemical References

• Antineoplastic Agents
• Malonates
• Organoplatinum Compounds
• SKI 2053R

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Antineoplastic Agents (administration & dosage, therapeutic use, toxicity)
• Female
• Humans
• Male
• Malonates (administration & dosage, therapeutic use, toxicity)
• Middle Aged
• Organoplatinum Compounds (administration & dosage, therapeutic use, toxicity)
• Stomach Neoplasms (drug therapy)