Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Cancer

Refractory Solid Tumor

Eligibility:

All Genders

1-18 years

Phase:

PHASE1

Brief 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 wit...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT00110357

Start Date

August 1 2005

End Date

March 1 2008

Last Update

December 24 2015

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Phoenix Children'S Hospital

Phoenix, Arizona, United States, 85016

2

University Of Arizona Health Sciences Center

Tucson, Arizona, United States, 85724

3

The Children'S Hospital

Denver, Colorado, United States, 80218

4

University Of Florida

Gainesville, Florida, United States, 32610