Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

Inclusion Criteria

• Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx.
• No previous radiation therapy or chemotherapy.
• No evidence of distant metastatic disease.
• Age > 18.
• Karnofsky performance status of > 60 (ECOG 2).
• ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60.
• Study-specific informed consent form.
• Protocol treatment must begin 5 years are eligible.

Exclusion Criteria

• Radiologic evidence of bone destruction.
• Previous or concurrent head and neck primaries.
• Prior surgery to study site other than biopsy.
• Patients receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).