Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and Neck

Inclusion Criteria:- Patients must have pathologically confirmed recurrence (reappearance
of previously cleared) squamous cell cancer primary in the upper aerodigestive tract or a
second squamous cell primary (excluding nasopharynx or salivary gland tumors). Patients may
have experienced more than one recurrence as long as the first recurrence occurred greater
than or equal to 6 months following the end of the prior RT.

   - The recurrence or second primary must have defined bi- or uni-dimensional
   measurements.

   - Recurrence or second primary must be confined to the head and neck above the clavicles
   (loco-regional recurrence).

   - The patient must not be a candidate for complete surgical resection. The previous
   irradiation must not exceed a maximum of 75 Gy.

   - The entire tumor volume must be included in a treatment field that limits the total
   spinal cord dose to 50 Gy (prior RT and anticipated RT).

   - Patients must be at least 6 months from prior radiation therapy.

   - Patients may have received prior chemotherapy as a component of their primary
   treatment, but not for recurrent disease.

   - Zubrod performance status 0-1.

   - Granulocytes greater than or equal to 1500/mm3, platelets greater than or equal to
   100,000/mm3, serum bilirubin less than or equal to 1.5 mg/dl, creatinine less than or
   equal to 1.5 mg/dl within 2 weeks prior to registration.

   - LFT's less than or equal to 2 x normal (SGOT/SGPT/Alkaline Phosphatase). If greater
   than 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative
   for metastases, patients are eligible.

   - Must be able to submit previous radiation records, including simulation and portal
   films, in order to assure that cord tolerance is not exceeded.

   - Patients must sign a study-specific informed consent form prior to study entry.
   Exclusion Criteria:- Primary in the nasopharynx or the salivary gland.

   - Intercurrent medical illnesses which would impair patient tolerance to therapy or
   limit survival.

   - A history of allergic reactions attributed to compounds of similar chemical or
   biologic composition to ZD1839 or other agents used in study.

   - Pregnant and nursing women are excluded because of the potential teratogenic effects
   and potential unknown effects on nursing newborns.