A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

- Squamous carcinoma of the head and neck.

- Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx

- Squamous carcinoma in cervical nodes no identified primary site

- Must be considered to have low cure rates with local therapy

- Previously untreated with chemotherapy or radiation therapy.

- Able to perform activities of daily living without assistance

- Adequate bone marrow, liver, and kidney function

- Mild peripheral neuropathy is allowed

- Measurable or evaluable disease

- Voluntarily give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Age < 18 years

- History of prior malignancy within the last five years

- Severe or uncontrolled systemic disease

- Significant clinical disorder or laboratory finding

- Women who are pregnant or breast-feeding

- Active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.