PMID: 8611374Mar 1, 1996Paper

Phase I and pharmacological study of the new topoisomerase I inhibitor GI147211, using a daily x 5 intravenous administration

British Journal of Cancer
C J GerritsJ Verweij

Abstract

Topoisomerase I inhibitors are interesting anti-cancer agents with a novel mechanism of action. We performed a phase I study with intravenous GI147211, a new semisynthetic camptothecin analogue, using a daily x 5 schedule administered every 3 weeks, to evaluate the side-effects and pharmacokinetics of the agent. Patients with a histologically confirmed diagnosis of a solid tumour refractory to standard froms of therapy were eligible for the study. GI147211 was given as a 30 min intravenous infusion daily for 5 consecutive days, repeated every 3 weeks. In subsequent patient cohorts the dose was escalated from 0.3 to 1.5 mg m-2 day-1. Pharmacokinetics analysis was performed on days 1 and 4 of the first course using a validated high-performance liquid chromatographic assay and non-compartmental methods. A total of 19 patients were entered into the study, one patient was not evaluable for toxicity because only one drug administration was given. Eighteen patients received a total of 67 courses through four dose levels. The dose-limiting toxicities were neutropenia and thrombocytopenia at the dose of 1.5 mg m-2 day-1. Nadirs occurred on day 15 and day 15 respectively. Other toxicities were mild and infrequent and included nausea/vomi...Continue Reading

Citations

Apr 6, 2001·Anti-cancer Drugs·J P DesjardinsF C Richardson
Sep 25, 2002·Drugs·Hulya Ulukan, Peter W Swaan
Mar 23, 2001·Anti-cancer Drugs·D F KehrerA Sparreboom
Mar 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Diederik F S KehrerElisabeth G E de Vries
Mar 20, 2001·Current Oncology Reports·Y Ohe, N Saijo
Jul 20, 2005·Anti-cancer Drugs·Ralf-Dieter HofheinzAndreas Hochhaus
Apr 27, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Whitney P CaronWilliam C Zamboni
Jan 30, 2010·Molecular Pharmaceutics·Vincent J Venditto, Eric E Simanek
Jan 31, 2002·Journal of Chromatography. B, Biomedical Sciences and Applications·L ZufíaJ Giráldez
Nov 14, 1997·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M L Rothenberg
Jun 4, 1999·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J P StevensonC Twelves

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