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Sponsors and Collaborators: |
Bristol-Myers Squibb ImClone Systems |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00110357 |
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 |
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Cancer Refractory Solid Tumor |
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 |
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 |
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Group A: Active Comparator
1-12 years old
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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)
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Group B: Active Comparator
13-18 years old
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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)
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Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Cetuximab Irinotecan |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |