Cetuximab, Chemotherapy, and Radiation Therapy for Operable Stage III or IV Head and Neck Cancer

INCLUSION CRITERIA

• Locally advanced (Stage III/IV), but potentially operable squamous cancer of the head and neck (exclude nasopharynx). Primary site biopsies must have had proven for cancer, nodal status, confirmed by clinical and pathologic exam with fine needle aspiration cytology recommended.
• ECOG performance status 0 - 1.
• Adequate laboratory index (ANC > 1500/mm3, platelets > 100,000/mm3, creatinine 1.5mg/dl, bilirubin 1.5mg/dl) completed within 4 weeks prior to registration.
• Surgical resectability:
• Included patients with operative stage III/IV disease, high likelihood of achieving R0 resection (complete resection with clean margins indicating NO residual cancer).
• Measurable disease, biopsy proven at primary site. Patients with clinically palpable cervical nodes were to have evaluation by CT scan and fine needle aspiration (FNA) confirmation of disease. Patients with non-palpable neck nodes had CT determination. In the absence of clinically palpable nodes, radiographic findings were acceptable.
• At least one objective measurable disease parameter in the primary site or neck.
• Baseline measurements or evaluations must have had obtained within 4 weeks prior to registration in the study.
• Age > 18 years.
• Women of childbearing potential and sexually active males were strongly advised to use an accepted and effective method of contraception.
• Original diagnostic materials must have had submitted for baseline EGFR assessment by the designated laboratory.

EXCLUSION CRITERIA

• Patients with fixed nodal metastases to spine or carotid artery, patients with invasion of root of tongue, pharyngeal muscle, post pharynx, or vertebral fascia or invasion of laryngeal cartilage into strap muscles or tracheal (>1cm) invasion.
• Prior chemotherapy, surgery radiation or immunotherapy for head and neck cancer.
• Prior malignancies except in situ lobular breast carcinoma, in situ cervical carcinoma, basal cell cancers or previously excised and controlled cutaneous squamous cancer (<200 mm thick) were permitted.
• Significant history of cardiac disease i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias.
• Prior anti-epidermal growth factor receptor antibody therapy or therapy with a tyrosine kinase inhibitor including inhibitors targeting EGFR pathway.
• Prior chimerized or murine monoclonal antibody therapy or known allergy to murine proteins or cremophor EL.
• Pregnant or breast-feeding women. All females of childbearing potential must have had a blood test or urine study within 72 hours of study entry and must not have had started therapy until 5 days after registration was over to rule out pregnancy.