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Annals of Oncology Advance Access published online on July 24, 2009
Annals of Oncology, doi:10.1093/annonc/mdp315
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors

W. T. Lim1, E. H. Tan1, C. K. Toh1, S. W. Hee2, S. S. Leong1, P. C. S. Ang1, N. S. Wong1 and B. Chowbay3,*

1 Department of Medical Oncology
2 Biostatistic Unit, Division of Clinical Trials and Epidemiological Sciences
3 Clinical Pharmacology Laboratory, Division of Medical Sciences, Humphrey Oei Institute of Cancer Research, National Cancer Centre, Singapore

* Correspondence to: Assoc Prof. B. Chowbay, Division of Medical Sciences, Humphrey Oei Institute of Cancer Research, National Cancer Centre, 11 Hospital Drive, Singapore 169610. Tel: +65-6436-8321; Fax: +65-6372-0161; E-mail: ctebal{at}nccs.com.sg

Background: The aim of this study was to determine the maximum tolerated dose (MTD) and the pharmacokinetic profile of Genexol-PM in Asian cancer patients.

Materials and methods: Patients (N = 24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80 mg/m2 and the maximum administered dose was 200 mg/m2.

Results: The majority of patients had lung, nasopharyngeal and breast cancers and in eleven patients (46%), taxane-based chemotherapy had previously failed. The MTD was defined at 180 mg/m2. The most common grade 3 non-hematologic adverse events in cycle 1 were fatigue (4%) and neuropathy (4%) occurring mainly at 200 mg/m2. Five (21%) patients had partial response, nine (38%) had stable disease and seven (29%) had disease progression. Five of 11 previously taxane-refractory patients showed clinical benefit to Genexol-PM. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both the maximum concentration (Cmax) and the area under the concentration-time curve from zero to infinity (AUC0–{infty}) increasing by approximately four- and threefold, respectively, as the dose of Genexol-PM was escalated from 80 to 200 mg/m2. The median total-body clearance of Genexol-PM for all patients was 43.9 l/h.

Conclusion: The weekly regimen of Genexol-PM was well tolerated and responses were observed in patients with refractory tumors, including patients who had failed taxane-based chemotherapy previously.

Asian, Genexol-PM, pharmacokinetics, phase 1, weekly regime

Received for publication February 20, 2009. Revision received May 4, 2009. Revision received May 7, 2009. Accepted for publication May 8, 2009.


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