Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
1 other identifier
interventional
48
1 country
9
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 with refractory solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 cancer
Started Aug 2005
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2005
CompletedFirst Posted
Study publicly available on registry
May 9, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
August 11, 2009
CompletedDecember 24, 2015
November 1, 2015
2.6 years
May 6, 2005
April 21, 2009
November 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)
Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.
Secondary Outcomes (13)
Number of Participants With a Dose-Limiting Toxicity
Prior to each 21-day cycle until dose-limiting toxicities
Maximum Plasma Concentration (Cmax)
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Area Under the Curve, Extrapolated to Infinity (AUC[INF])
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Terminal Half-Life (T-Half)
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
Clearance Corrected for Body Surface Area (CL/BSA)
up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
- +8 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATOR1-12 years old
Group B
ACTIVE COMPARATOR13-18 years old
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Phoenix Children'S Hospital
Phoenix, Arizona, 85016, United States
University Of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
The Children'S Hospital
Denver, Colorado, 80218, United States
University Of Florida
Gainesville, Florida, 32610, United States
Children'S Healthcare Of Atlanta
Atlanta, Georgia, 30322, United States
Sidney Kimmel Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Vanderbilt University Medical Center Infectious Diseases
Nashville, Tennessee, 37232, United States
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 19770383BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2005
First Posted
May 9, 2005
Study Start
August 1, 2005
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
December 24, 2015
Results First Posted
August 11, 2009
Record last verified: 2015-11