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Annals of Oncology Advance Access published online on November 25, 2009
Annals of Oncology, doi:10.1093/annonc/mdp549
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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

Cetuximab administered once every second week to patients with metastatic colorectal cancer: a two-part pharmacokinetic/pharmacodynamic phase I dose-escalation study

J. Tabernero1,*, F. Ciardiello2, F. Rivera3, E. Rodriguez-Braun4, F. J. Ramos1, E. Martinelli2, M. E. Vega-Villegas3, S. Roselló4, S. Liebscher5, O. Kisker6, T. Macarulla1, J. Baselga1 and A. Cervantes4

1 Medical Oncology Service, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain
2 Division of Medical Oncology, Department of Experimental and Clinical Medicine ‘F. Magrassi and A. Lanzara’, Second University of Naples, Naples, Italy
3 Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander
4 Department of Hematology and Medical Oncology, Hospital Clinico Universitario, University of Valencia, Spain
5 Global Biostatistics
6 Medical Sciences Oncology, Merck KGaA, Darmstadt, Germany

* Correspondence to: Dr J. Tabernero, Medical Oncology Department, Vall d'Hebron University Hospital, P. Vall d'Hebron, 119–129, 08035 Barcelona, Spain. Tel: +34-93-274-6085; Fax: +34-93-274-6059; E-mail: jtabernero{at}vhebron.net

Background: This phase I dose-escalation study was designed to determine the maximum tolerated dose (MTD) and recommended dose of cetuximab administered on an every-second-week schedule to patients with metastatic colorectal cancer, on the basis of safety, pharmacokinetic and pharmacodynamic evaluation.

Patients and methods: The study comprised two parts: a 6-week cetuximab monotherapy dose-escalation phase and a subsequent combination therapy phase, during which patients received cetuximab, at the same dose/schedule as in the monotherapy phase, followed by irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI). Patients in the control group received cetuximab as a 400 mg/m2 initial dose, then 250 mg/m2/week and in the dose-escalation group, at 400–700 mg/m2, every second week.

Results: Sixty-two patients were included in the study. The MTD of cetuximab administered on an every-second-week schedule was not reached. The safety profiles were similar across all groups. Response rates in the cetuximab monotherapy and combination therapy phases were 15% and 42%, respectively. Trough levels for the 500, 600 mg/m2 and standard weekly regimens were comparable.

Conclusion: Cetuximab can be safely administered once every second week at doses between 400 and 700 mg/m2, with 500 mg/m2 being the most convenient and feasible dose for future studies.

cetuximab, EGFR, every second week, metastatic colorectal cancer, pharmacokinetics

Received for publication July 31, 2009. Revision received October 27, 2009. Accepted for publication October 28, 2009.


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