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

Inclusion Criteria

• 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 and/or measurable disease. (Based on Union for International Cancer Control (UICC)/World Health Organization (WHO) Criteria)
• Eastern Cooperative Oncology Group (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 white blood count (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.
• Women of childbearing potential and men must be willing to practice acceptable methods of birth control to prevent pregnancy.

Exclusion Criteria

• Prior ZD1839 or other Epidermal growth factor receptor (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 Common Terminology Criteria (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., Prothrombin time (PT) or Partial thromboplastin time (PTT)).
• Absolute neutrophil count (ANC) less than 1,500/mm**3 or platelets less than 100,000/mm**3.
• 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 Upper Limit of the Reference Range (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 an uncontrolled seizure disorder or active neurological disease.
• The patient has received any non-approved or investigational agent(s) within 30 days before Day 1 of study treatment.
• Known, severe hypersensitivity to ZD1839 or any of the excipients of this product.
• Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable radiographic changes who are asymptomatic need not be excluded).