ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Condition: Skin Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Skin Neoplasms
Intervention: Iressa
Intervention description: 250 mg by mouth daily
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Skin Cancer; Squamous Cell Carcinoma of the Skin; Gefitinib; ZD1839; Iressa; Epidermal Growth Factor Receptor; EGFR

Summary:

      The goal of this clinical research study is to learn if the drug ZD1839 (Iressa) can shrink
      or slow the growth of cancer in participants with recurrent and/or metastatic squamous cell
      cancer (SCC) of the skin. The safety of this drug will also be studied.
    

Eligibility criteria:

        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).