Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
NCT ID: NCT00110357
Last Updated: 2015-12-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2005-08-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Group A
1-12 years old
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.
Group B
13-18 years old
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Children age 1-18 years.
Exclusion Criteria
* Requirement to receive concurrent chemotherapy immunotherapy, radiotherapy, or any other investigational drug while on study.
* Inadequate bone marrow, hepatic, or renal function.
1 Year
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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References
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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.
Other Identifiers
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CA225-085
Identifier Type: -
Identifier Source: org_study_id