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

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Josep TaberneroAndres Cervantes

Abstract

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. 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/m(2) initial dose, then 250 mg/m(2)/week and in the dose-escalation group, at 400-700 mg/m(2), every second week. 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/m(2) and standard weekly regimens were comparable. Cetuximab can be safely administered once every second week at doses between 400 and 700 mg/m(2), wit...Continue Reading

Associated Clinical Trials

References

Nov 1, 1996·Journal of Immunotherapy with Emphasis on Tumor Immunology : Official Journal of the Society for Biological Therapy·M PrewettN I Goldstein
Mar 3, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Leonard B SaltzRobert J Mayer
Jul 23, 2004·The New England Journal of Medicine·David CunninghamEric Van Cutsem
Jul 30, 2005·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Catherine DelbaldoEric Raymond
Aug 21, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Wu ZhangHeinz-Josef Lenz
Nov 16, 2007·The New England Journal of Medicine·Derek J JonkerMalcolm J Moore
Feb 19, 2008·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P PfeifferB Jensen
Apr 9, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Alberto F SobreroHoward A Burris
Dec 31, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Carsten BokemeyerPiotr Koralewski
Apr 3, 2009·The New England Journal of Medicine·Eric Van CutsemPhilippe Rougier

❮ Previous
Next ❯

Citations

Jan 18, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·B Glimelius, M Lahn
Jan 30, 2013·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·A CarratoE Aranda
Apr 25, 2012·Journal of Cancer Research and Clinical Oncology·S AbdelwahabA Mahmoud
Dec 24, 2011·Clinical Colorectal Cancer·Thomas H Cartwright
Feb 14, 2013·International Journal of Cancer. Journal International Du Cancer·Emanuele ValtortaFederica Di Nicolantonio
Jul 6, 2016·Journal of Pharmacokinetics and Pharmacodynamics·Patrick M Glassman, Joseph P Balthasar
Jan 27, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Josep TaberneroFortunato Ciardiello
Apr 10, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Le-Chi YeJianmin Xu
Dec 17, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Randy F SweisMark J Ratain
Jun 5, 2019·Future Oncology·Francesco Saverio MenniniNicola Personeni
Sep 16, 2016·Therapeutic Drug Monitoring·Yoann PointreauGilles Paintaud
Nov 11, 2019·European Journal of Nuclear Medicine and Molecular Imaging·E J van HeldenC W Menke-van der Houven van Oordt
Aug 11, 2017·European Journal of Drug Metabolism and Pharmacokinetics·Joannes A A ReijersMatthijs Moerland
Oct 17, 2019·Frontiers in Oncology·Jesús García-FoncillasSebastian Stintzing
Apr 16, 2019·Current Opinion in Oncology·Joël GuigayCécile Mertens
Oct 6, 2020·CPT: Pharmacometrics & Systems Pharmacology·Ana-Marija GrisicCharlotte Kloft
Oct 21, 2020·CPT: Pharmacometrics & Systems Pharmacology·Jérémy SeuratFrance Mentré
Sep 29, 2011·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nicolas AzzopardiGilles Paintaud
Sep 1, 2021·Cellular Oncology (Dordrecht)·Alexandros GeorgiouUdai Banerji

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.