Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

Inclusion Criteria:

• Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
• Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
• Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
• No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
• Eastern Cooperative Oncology Group performance status </= 1
• Women of child-bearing potential must have a negative pregnancy test within 30 hours before initiation of study drug dosing. Female subjects of reproductive potential must agree to avoid pregnancy throughout the study and for up to 3 months following discontinuation of study drug. Male subjects must agree to avoid conceiving a child throughout the study and for up to 3 months following discontinuation of study drug;
• Hemoglobin >/= 8.0 gm/dL
• Absolute neutrophil count >/= 1500
• Platelet count >/= 100,000
• Glomerular Filtration Rate > 50 mL/min calculated by the Cockcroft-Gault equation
• Total bilirubin </= 2.0 times the upper limit of normal unless the patient has Gilbert's syndrome
• Aspartate aminotransferase and Alanine Aminotransferase </= 2.5 times the upper limit of normal
• No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for >/= 3 years prior to screening for this protocol.
• Age of 18 or older
• Ability and willingness to give informed consent
• Subjects must in the opinion of the Investigator be capable of complying with this protocol.

Exclusion Criteria:

• Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
• Major surgery within 3 weeks prior to study entry
• Known hypersensitivity to cisplatin or cetuximab
• Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction </= 6 months prior to study entry.
• Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
• Patients unwilling to comply with the protocol, or provide informed consent
• Psychiatric illness that would limit compliance with study requirements