Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	ImClone LLC
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00110357

Purpose

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.

Condition	Intervention	Phase
Cancer Refractory Solid Tumor	Drug: Cetuximab + Irinotecan Drug: Cetuximab + Irinotecan	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan [ Time Frame: Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With a Dose-Limiting Toxicity [ Time Frame: Prior to each 21-day cycle until dose-limiting toxicities ] [ Designated as safety issue: Yes ]
Maximum Plasma Concentration (Cmax) [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ] [ Designated as safety issue: No ]
Area Under the Curve, Extrapolated to Infinity (AUC[INF]) [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ] [ Designated as safety issue: No ]
Terminal Half-Life (T-Half) [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ] [ Designated as safety issue: No ]
Clearance Corrected for Body Surface Area (CL/BSA) [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ] [ Designated as safety issue: No ]
Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA) [ Time Frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ] [ Designated as safety issue: No ]
Tumor Response [ Time Frame: Every other 21-day cycle ] [ Designated as safety issue: No ]
Human Anti-cetuximab Antibody (HACA) Response [ Time Frame: Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle ] [ Designated as safety issue: Yes ]
Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) [ Time Frame: Weekly throughout the study and every 4 weeks thereafter ] [ Designated as safety issue: Yes ]
Grade 3-4 Laboratory Abnormalities - Leukopenia [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ] [ Designated as safety issue: Yes ]
Grade 3-4 Laboratory Abnormalities - Neutropenia [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ] [ Designated as safety issue: Yes ]
Grade 3-4 Laboratory Abnormalities - Thrombocytopenia [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ] [ Designated as safety issue: Yes ]
Grade 3/4 Laboratory Abnormalities - Hypomagnesemia [ Time Frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	August 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator 1-12 years old	Drug: 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: Active Comparator 13-18 years old	Drug: 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

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110357

Locations

United States, Arizona
University Of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Phoenix Children'S Hospital
Phoenix, Arizona, United States, 85016
United States, Colorado
The Children'S Hospital
Denver, Colorado, United States, 80218
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Children'S Healthcare Of Atlanta
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Vanderbilt University Medical Center Infectious Diseases
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030

Sponsors and Collaborators

Bristol-Myers Squibb

ImClone LLC

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Phrma website - CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA225-085
Study First Received:	May 6, 2005
Results First Received:	April 21, 2009
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00110357 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Cetuximab

Irinotecan
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009