| Exclusion Criteria: | Treatment with radiotherapy, chemotherapy, immunotherapy, vaccine treatment, and/or alternative anti-cancer treatments (including investigational drugs) within the preceding 30 days.
Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
The presence of advanced symptomatic central nervous system involvement by melanoma or a requirement for steroids and/or phenytoin, spinal cord compression, or meningeal carcinomatosis.
Other co-existing malignancies or malignancies diagnosed within the preceding 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.
Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
Patients who are pregnant or lactating are not eligible. Pts. must have a negative pregnancy test at screening. Both men and women of childbearing potential must practice adequate birth control for the duration of the study and for one year after.
Inability to return for follow up re-evaluation and assessment of response to therapy.
Requirement for concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's Wort.
Any evidence of clinically active interstitial lung disease (pts. with chronic stable radiographic changes who are asymptomatic need not be excluded.
Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
Incomplete healing from previous oncologic or other major surgery.
Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Evidence of any other significant clinical disorder or lab finding that makes it undesirable for the subject to participate in the trial.
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
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