| Exclusion Criteria: | 1) Prior ZD1839 or other 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 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., PT or PTT).
6) 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 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 ILD (patients with chronic, stable radiographic changes who are asymptomatic need not be excluded). |