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A phase I study of lobaplatin (D-19466) administered by 72 h continuous infusion

 

作者: Jourik Gietema,   Henk-Jan Guchelaar,   Elisabeth de Vries,   Paul Aulenbacher,   Dirk Th Sleijfer,   Nanno Mulder,  

 

期刊: Anti-Cancer Drugs  (OVID Available online 1993)
卷期: Volume 4, issue 1  

页码: 51-55

 

ISSN:0959-4973

 

年代: 1993

 

出版商: OVID

 

关键词: Continuous infusion;D-19466;lobaplatin;phase I study

 

数据来源: OVID

 

摘要:

A phase I trial with continuous intravenous infusion of lobaplatin (D-19466; 1,2-diamminomethyl-cyclobutaneplatinum (ll)-lactate) for 72 h was performed to determine the maximum tolerated dose (MTD). Each patient received a single dose level, the total dose of lobaplatin ranged from 30 to 60 mg/m2/72 h every 4 weeks. Eleven patients enroled in this study and received a total of 30 courses of lobaplatin (median 2; range 1–6). Thrombocytopenia was the dose-limiting toxicity, it reached WHO grade III in three out of six patients at 45 mg/m2/72 h, and WHO grade IV in two out of two patients at 60 mg/m2/72 h. Leucocytopenia was mild, as was nausea and vomiting. Phlebitis at the infusion site was found in three patients. During this trial there were no signs of renal, neuro- or ototoxicity. One patient with ovarian cancer, pretreated with three different platinum complexes, achieved a partial response now lasting for longer than 6 months. In conclusion, thrombocytopenia is the dose-limiting toxicity of lobaplatin administered by 72 h continuous infusion. The recommended phase II dose for this regimen is 45 mg/m2/72 h every 4 weeks.

 

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