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

Lilly

Status and phase: Completed; Phase 1

Conditions: Cancer; Refractory Solid Tumor

Treatments: Drug: Cetuximab + Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110357

CA225-085

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of a solid tumor which has progressed on, or following standard therapy, or for which no standard effective therapy is known.
• Children age 1-18 years.

Exclusion criteria

• Presence of active infection.
• Requirement to receive concurrent chemotherapy immunotherapy, radiotherapy, or any other investigational drug while on study.
• Inadequate bone marrow, hepatic, or renal function.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Group A

Active Comparator group

Description:

1-12 years old

Treatment:

Drug: Cetuximab + Irinotecan

Drug: Cetuximab + Irinotecan

Group B

Active Comparator group

Description:

13-18 years old

Treatment:

Drug: Cetuximab + Irinotecan

Drug: Cetuximab + Irinotecan