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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