Title |
Escalating weekly doses of cetuximab and correlation with skin toxicity: A phase I study
|
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Published in |
Investigational New Drugs, February 2010
|
DOI | 10.1007/s10637-010-9396-4 |
Pubmed ID | |
Authors |
Cheryl Ho, Randeep Sangha, Laurel Beckett, Michael Tanaka, Derick H. Lau, Daniel B. Eisen, Rachel A. Burich, Paul Luciw, Imran Khan, Philip C. Mack, David R. Gandara, Angela M. Davies |
Abstract |
Cetuximab is a chimeric monoclonal antibody targeting the epidermal growth factor receptor (EGFR). The recommended dosage is an initial load of 400 mg/m² intravenously (IV) followed by a weekly maintenance dose of 250 mg/m². It has been reported retrospectively that cetuximab efficacy was correlated with dose-related severity of skin rash. This study was prospectively designed to examine the safety and feasibility of escalating weekly doses of cetuximab, testing the hypothesis of the relationship of dose-dependent skin toxicity and efficacy. Methods Four dose levels were tested: Cetuximab 400 mg/m² IV loading dose and 250, 300, 350, 400 mg/m² weekly IV maintenance. There was no intra-patient dose escalation. Standard dose limiting toxicity criteria were used. Rash was evaluated using two additional validated dermatology methods: global acne grading scale (GAGS) and acne lesion counting (ALC). Tumor specimens and blood samples were obtained for correlative analyses. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Japan | 1 | 2% |
United States | 1 | 2% |
Unknown | 48 | 96% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 9 | 18% |
Other | 7 | 14% |
Student > Bachelor | 5 | 10% |
Student > Ph. D. Student | 5 | 10% |
Professor > Associate Professor | 5 | 10% |
Other | 12 | 24% |
Unknown | 7 | 14% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 23 | 46% |
Agricultural and Biological Sciences | 6 | 12% |
Pharmacology, Toxicology and Pharmaceutical Science | 3 | 6% |
Biochemistry, Genetics and Molecular Biology | 2 | 4% |
Immunology and Microbiology | 2 | 4% |
Other | 6 | 12% |
Unknown | 8 | 16% |