Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Refractory Solid Tumor
Intervention: Cetuximab + Irinotecan (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
Official title: Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: Characterize the serum pharmacokinetics of cetuximab in pediatric and adolescent subjects with refractory solid tumors.Evaluate the safety profile and determine the dose limiting toxicities of the combination of cetuximab and irinotecan. Evaluate preliminary evidence of anti-tumor activity of the combination of cetuximab and irinotecan in the subject population. Evaluate the incidence of human anti-cetuximab antibody formation in subjects receiving cetuximab.
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
University Of Arizona Health Sciences Center, Tucson, Arizona 85724, United States
Phoenix Children'S Hospital, Phoenix, Arizona 85016, 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
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: August 2005
Ending date: March 2008
Last updated: May 15, 2008
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