NCT00110357

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Refractory Solid Tumor

Interventions

Type	Name	Description
DRUG	Cetuximab + Irinotecan	Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
DRUG	Cetuximab + Irinotecan	Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-05-09
• Last updated: 2015-12-24
• Results posted: 2009-08-11

Locations

9 sites across 1 country: United States