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Journal of Clinical Oncology, Vol 19, Issue 13 (July), 2001: 3234-3243
© 2001 American Society for Clinical Oncology

Phase I Study of Anti–Epidermal Growth Factor Receptor Antibody Cetuximab in Combination With Radiation Therapy in Patients With Advanced Head and Neck Cancer

By Francisco Robert, Mark P. Ezekiel, Sharon A. Spencer, Ruby F. Meredith, James A. Bonner, M. B. Khazaeli, Mansoor N. Saleh, Delicia Carey, Albert F. LoBuglio, Richard H. Wheeler, Michael R. Cooper, Harlan W. Waksal

From the Division of Hematology/Oncology, Department of Radiation Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, and Birmingham Veterans Administration, Birmingham, AL; University of Utah Medical Center, Salt Lake City, UT; and ImClone Systems, Inc, Somerville, NJ.

Address reprint requests to Francisco Robert, MD, University of Alabama at Birmingham, Comprehensive Cancer Center, Wallace Tumor Institute, Rm 230, 1824 Sixth Ave South, Birmingham, AL 35294-3300; email: pacorobertuab{at}cs.com

PURPOSE: To evaluate the safety, pharmacokinetics, and efficacy of a chimeric anti–epidermal growth factor receptor monoclonal antibody, cetuximab, in combination with radiation therapy (RT) in patients with advanced squamous cell carcinoma of the head and neck.

PATIENTS AND METHODS: We treated 16 patients in five successive treatment schedules. A standard dose escalation procedure was used; three patients entered onto the study at each dose level of cetuximab received conventional RT (70 Gy, 2 Gy/d), and the final three patients received hyperfractionated RT (76.8 Gy, 1.2 Gy bid). Cetuximab was delivered as a loading dose of 100 to 500 mg/m2, followed by weekly infusions of 100 to 250 mg/m2 for 7 to 8 weeks. Circulating levels of cetuximab during therapy were determined using a biomolecular interaction analysis core instrument. Human antichimeric antibody response was evaluated with a double-antigen radiometric assay. The recommended phase II/III dose was defined as the optimal cetuximab dose level based on the pharmacologic parameters and adverse events.

RESULTS: The most commonly reported adverse events were fever, asthenia, transaminase elevation, nausea, and skin toxicities (grade 1 to 2 in most patients). Skin toxicity outside of the RT field was not strictly dose-dependent; however, grade 2 or higher events were observed in patients treated with higher dose regimens. There was one grade 4 allergic reaction. Most acute adverse effects were associated with RT (xerostomia, mucositis, and local skin toxicity). No antibodies against cetuximab were detected. All patients achieved an objective response (13 complete and two partial remissions).

CONCLUSION: Cetuximab can be safely administered with RT. The recommended dose for phase II/III studies is a loading dose of 400 to 500 mg/m2 and a maintenance weekly dose of 250 mg/m2.


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