Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

Phase 1 Completed 48 enrolled Eli Lilly and Company

Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.

Timeline

Start: 2005-08
Primary completion: 2008-03
Completion: 2008-03

Publications

Background Trippett TM, Herzog C, Whitlock JA, Wolff J, Kuttesch J, Bagatell R, Hunger SP, Boklan J, Smith AA, Arceci RJ, Katzenstein HM, Harbison C, Zhou X, Lu H, Langer C, Weber M, Gore L. Phase I and pharmacokinetic study of cetuximab and irinotecan in children with refractory solid tumors: a study of the pediatric oncology experimental therapeutic investigators' consortium. J Clin Oncol. 2009 Oct 20;27(30):5102-8. doi: 10.1200/JCO.2008.20.8975. Epub 2009 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cetuximab	Monoclonal antibody	75 mg/m2	Intravenous
Comparator	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Comparator	Irinotecan	Small molecule	16 mg/m2	Intravenous
Comparator	Irinotecan	Small molecule	20 mg/m2	Intravenous

Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

Summary

Timeline

Publications

Drugs

Indications