ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin

Inclusion Criteria:

1. Provision of written informed consent.
2. Pathologically confirmed locoregional recurrence and/or metastatic SCC of the skin not amenable to curative therapy (i.e., surgery or radiation).
3. Evaluable and/or measurable disease. (Based on Union for International Cancer Control (UICC)/World Health Organization (WHO) Criteria)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Adequate hematologic function as defined by an absolute neutrophil count >= 1,500/mm3, a platelet count >= 100,000/mm3, a white blood count (WBC) >= 3,000/ mm3, and a hemoglobin level of >= 9 g/dl.
6. Up to one prior chemotherapy regimen.
7. At least a 2-week recovery from prior therapy toxicity.
8. Age 18 years or older.
9. 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.
10. Women of childbearing potential and men must be willing to practice acceptable methods of birth control to prevent pregnancy.

Exclusion Criteria:

1. Prior ZD1839 or other Epidermal growth factor receptor (EGFR) inhibiting agents.
2. Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ.
3. Any unresolved chronic toxicity greater then Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy.
4. Incomplete healing from previous oncologic or other major surgery.
5. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort. Patients taking anticoagulants must have coagulation parameters followed (i.e., Prothrombin time (PT) or Partial thromboplastin time (PTT)).
6. Absolute neutrophil count (ANC) less than 1,500/mm**3 or platelets less than 100,000/mm**3.
7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
8. 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).
9. 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 Upper Limit of the Reference Range (ULRR) in the presence of liver metastases.
10. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
11. Pregnancy or breast feeding (women of child-bearing potential)
12. The patient has an uncontrolled seizure disorder or active neurological disease.
13. The patient has received any non-approved or investigational agent(s) within 30 days before Day 1 of study treatment.
14. Known, severe hypersensitivity to ZD1839 or any of the excipients of this product.
15. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable radiographic changes who are asymptomatic need not be excluded).