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

Sponsors and Collaborators:	Bristol-Myers Squibb ImClone Systems
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	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Establish the Maximum Tolerated Dose and Recommended phase 2 dose of cetuximab in combination with irinotecan in pediatric subjects and in adolescent subjects with refractory solid tumors. [ Time Frame: by 30-June-2007 (may be extended if FDA agrees) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Characterize the serum pharmacokinetics of cetuximab in pediatric and adolescent subjects with refractory solid tumors. [ Time Frame: by 30-June-2007 (may be extended if the FDA agrees) ] [ Designated as safety issue: No ]
Evaluate the safety profile and determine the dose limiting toxicities of the combination of cetuximab and irinotecan. [ Time Frame: 30-June-2007 ] [ Designated as safety issue: Yes ]
Evaluate the incidence of human anti-cetuximab antibody formation in subjects receiving cetuximab. [ Time Frame: 30-Jun-2007 ] [ Designated as safety issue: Yes ]
Evaluate preliminary evidence of anti-tumor activity of the combination of cetuximab and irinotecan in the subject population. [ Time Frame: 30-Jun-2007 ] [ Designated as safety issue: No ]

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 IV, IV, Cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; Irinotecan X 5d X 2 wks Q 21 days (every 3 weeks)
Group B: Active Comparator 13-18 years old	Drug: Cetuximab + Irinotecan IV, IV, Cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; Irinotecan X 5d X 2 wks Q 21 days (every 3 weeks)

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 Systems

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA225-085
Study First Received:	May 6, 2005
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00110357
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cetuximab
Irinotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009