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

Completed · Phase 1

Conditions studied: Cancer, Refractory Solid Tumor

In brief

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.

Key facts

Study ID

NCT00110357

Run by

Eli Lilly and Company

People needed

48

Starts

2005-08-01

Expected to finish

2008-03-01

Last updated by the study team

2015-12-24

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Children'S Hospital — Phoenix, Arizona, United States
• University Of Arizona Health Sciences Center — Tucson, Arizona, United States
• The Children'S Hospital — Denver, Colorado, United States
• University Of Florida — Gainesville, Florida, United States
• Children'S Healthcare Of Atlanta — Atlanta, Georgia, United States
• Sidney Kimmel Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Vanderbilt University Medical Center Infectious Diseases — Nashville, Tennessee, United States
• University Of Texas Md Anderson Cancer Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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