Clinical trial NCT00110357: Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Official title: Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Refractory Solid Tumor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-05-09
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
timeFrame: 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:
measure: Number of Participants With a Dose-Limiting Toxicity
timeFrame: Prior to each 21-day cycle until dose-limiting toxicities
measure: Maximum Plasma Concentration (Cmax)
timeFrame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
measure: Area Under the Curve, Extrapolated to Infinity (AUC[INF])
timeFrame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
measure: Terminal Half-Life (T-Half)
timeFrame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
measure: Clearance Corrected for Body Surface Area (CL/BSA)
timeFrame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
measure: Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)
timeFrame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study
measure: Tumor Response
timeFrame: Every other 21-day cycle
measure: Human Anti-cetuximab Antibody (HACA) Response
timeFrame: Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle
measure: Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)
timeFrame: Weekly throughout the study and every 4 weeks thereafter
measure: Grade 3-4 Laboratory Abnormalities - Leukopenia
timeFrame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
measure: Grade 3-4 Laboratory Abnormalities - Neutropenia
timeFrame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
measure: Grade 3-4 Laboratory Abnormalities - Thrombocytopenia
timeFrame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
measure: Grade 3/4 Laboratory Abnormalities - Hypomagnesemia
timeFrame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children'S Hospital
state: Arizona
city: Tucson
country: United States
facility: University Of Arizona Health Sciences Center
state: Arizona
city: Denver
country: United States
facility: The Children'S Hospital
state: Colorado
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Atlanta
country: United States
facility: Children'S Healthcare Of Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Cancer Center At Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Infectious Diseases
state: Tennessee
city: Houston
country: United States
facility: University Of Texas Md Anderson Cancer Ctr
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.