Patients will receive 250 mg ZD1839 daily by mouth (1 course = 4 weeks). Patients will receive 6 courses of treatment. A patient may continue to receive treatment on this study if he or she has stable disease or response.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• Provision of written informed consent.
• Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin not amenable to curative therapy (i.e., surgery or radiation).
• Evaluable, measurable disease.
• ECOG performance status 0-2.
• Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a WBC >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl.
• Up to one prior chemotherapy regimen.
• At least a 2-week recovery from prior therapy toxicity.
• Age 18 years or older.
• Disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years. Patients with a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, completely resected breast cancer will not be excluded.

Exclusion:

• Prior ZD1839 or other EGFR inhibiting agents.
• Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ.
• Any unresolved chronic toxicity greater then CTC grade 2 from previous anticancer therapy.
• Incomplete healing from previous oncologic or other major surgery.
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort. Patients taking anticoagulants must have coagulation parameters followed (i.e., PT or PTT).
• Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L).
• Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
• In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
• Pregnancy or breast feeding (women of child-bearing potential)
• The patient has uncontrolled seizure disorder, active neurological disease.
• The patient has received any investigational agent(s) within 30 days of study entry.