Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer

Inclusion Criteria

• •Biopsy and/or fine needle aspirate of the tumor is required prior to registration. Pathologically confirmed primary squamous cell cancer of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary confined to the head and neck; histological variants such as spindle cell carcinoma, poorly differentiated keratin-positive carcinoma, and lymphoepithelioma are included. Patients with nasopharyngeal and salivary gland tumors are ineligible.
• •Measureable disease representing stage III or stage IVa or IVb cancer by AJCC staging is required (See Appendix II)
• •Measureable disease representing stage II cancer qualifies if the patient refuses surgery or is unable to undergo surgery as curative treatment
• •Patient must not have had previous irradiation or surgery other than biopsy of the head and neck region
• •A CT of the chest and CT or MRI of the tumor site is required within four weeks prior to registration
• •Appropriate staging evaluation is required within four weeks prior to registration, including the following:
• •history and physical examination with special attention to functional status measures, carotid arteries, neck and clavicular lymph nodes
• •chest CT with evaluation of any nodules ≥ 1cm with biopsy or PET/CT (patients with lesions \< 1cm, negative on PET scan, or that cannot be safely biopsied remain eligible).
• •ECOG performance status 0-2 (See Appendix III)
• •Age ≥ 18 years
• •Complete blood count evaluation within two weeks of treatment demonstrating absolute neutrophil count ≥ 1500/mm3, platelets ≥100,000 cells/mm3, and hemoglobin ≥ 8g/dL
• •Liver function tests within two weeks of treatment demonstrating total bilirubin ≤1.5 mg/dL, AST and ALT \< 2x upper limit of normal, and alkaline phosphatase \< 2x upper limits of normal; an abdominal CT scan is required if any of the above criteria are not met
• •Adequate renal function measured within two weeks of treatment, defined as a creatinine clearance ≥ 50 ml/min determined by a 24 hour urine creatinine or the Cockcroft-Gault equation, where creatinine clearance (ml/min) is equal to:
• •\[(140 - age) x (wt in kg)\] x 0.85 for females \[(sCR) x (72)\]
• •Corrected serum calcium \<11 mg/dL within two weeks prior to treatment.
• •Urine pregnancy test two weeks prior to treatment for women of childbearing potential; women of childbearing potential and male participants must agree to use a medically effective means of contraception throughout the duration of treatment and 30 days thereafter
• •All patients must sign study-specific informed consent prior to study entry.