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Vol. 84, No. 4, 2013
Issue release date: March 2013
Section title: Clinical Trial Notes
Oncology 2013;84:210–213
(DOI:10.1159/000346328)

A Phase II Study of High-Dose Cetuximab plus Irinotecan in Colorectal Cancer Patients with KRAS Wild-Type Tumors Who Progressed after Standard Dose of Cetuximab plus Irinotecan

Fora A.A.a · McMahon J.A.a · Wilding G.a · Groman A.a · Ma W.W.a · Romano K.S.a · Fakih M.G.b
aRoswell Park Cancer Institute, Buffalo, N.Y., and bCity of Hope, Duarte, Calif., USA

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Article / Publication Details

First-Page Preview
Abstract of Clinical Trial Notes

Received: 10/2/2012 8:12:35 AM
Accepted: 12/6/2012
Published online: 1/17/2013
Issue release date: March 2013

Number of Print Pages: 4
Number of Figures: 1
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Objectives: We conducted a phase II clinical trial of high-dose cetuximab plus irinotecan in KRAS wild-type patients who progressed on standard-dose cetuximab plus irinotecan. Methods: Patients who progressed within 4 weeks from receiving a minimum of 6 weeks of standard-dose cetuximab plus irinotecan were included in this study. Cetuximab was administered at 500 mg/m2/week and irinotecan was administered at the same dose/schedule on which each individual patient had previously progressed. The study was closed early after having met its primary end point. Results: Twenty patients were treated. The regimen was found to be efficacious, with 9 patients achieving disease control lasting more than 12 weeks. The median progression-free survival and overall survival were 2.8 and 6.6 months, respectively. The toxicity profile was favorable, with the exception of grade 3–4 hypomagnesemia which was noted in 25% of patients. Conclusions: High-dose cetuximab plus irinotecan rechallenge can re-elicit clinical benefits in patients who have previously failed cetuximab plus irinotecan treatment. The clinical benefits are modest and may be related to cetuximab rechallenge rather than cetuximab dose escalation.

© 2013 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Trial Notes

Received: 10/2/2012 8:12:35 AM
Accepted: 12/6/2012
Published online: 1/17/2013
Issue release date: March 2013

Number of Print Pages: 4
Number of Figures: 1
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


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