Phase II and pharmacokinetic study of GL331 in previously treated Chinese gastric cancer patients

Jacqueline Liu, Li Chen, Yee Chao, Anna Li, Chew Wu, Tai Shun Liu, Her Shiah, Jang Chang, Jong Chen, Hsiao Wu, Wei Lin, Chieh Lan, Jacqueline Whang-Peng

研究成果: Article同行評審

13 引文 斯高帕斯(Scopus)

摘要

Purpose: A phase II and pharmacokinetic study was designed to assess the efficacy and toxicity profile of an epidophyllotoxin analogue, GL331, in previously treated Chinese gastric cancer patients, with concurrent pharmacokinetic evaluation of the drug's metabolism. Material and methods: GL331 was given at 200 mg/m2 as a daily 3-h infusion for 5 days every 4 weeks. Results: Enrolled in the study were 15 patients. One patient died from neutropenic sepsis before evaluation, one patient did not receive the full dose for reasons unrelated to GL331, nine patients had progressive disease with a median survival of 80 days, and five had stable disease with a median survival of 240 days. Grade 3 and 4 myelosuppression occurred in 10 of the 15 patients, with one death from neutropenic sepsis. This patient's peak GL331 concentration was 16.8 μg/ml, which was high compared to the mean peak drug concentration of 6±4.1 μg/ml. The mean systemic GL331 clearance was 12.1±7.2 l/h per m2, much lower than 23.3±8.2 l/h per m2 found in the phase I trial. Topoisomerase IIα was determined by immunohistochemistry and overexpression was detected in 3 of 11 specimens. Conclusions: GL331 was ineffective at this dose and schedule in this group of patients in spite of adequate blood levels of the drug.

原文English
頁(從 - 到)425-428
頁數4
期刊Cancer Chemotherapy and Pharmacology
49
發行號5
DOIs
出版狀態Published - 2002

All Science Journal Classification (ASJC) codes

  • 腫瘤科
  • 毒理學
  • 藥理
  • 癌症研究
  • 藥學(醫學)

指紋

深入研究「Phase II and pharmacokinetic study of GL331 in previously treated Chinese gastric cancer patients」主題。共同形成了獨特的指紋。

引用此