Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

Inclusion Criteria:

• Subject must be able to provide informed consent
• Subject must be 18 years of age or older
• Subject must have histologically confirmed ACC by Department of Pathology at Dartmouth Hitchcock Medical Center
• Subject must have inoperable disease
• Subject must have received some form of systemic therapy prior to enrolling in the study

Exclusion Criteria:

• known severe hypersensitivity to Iressa
• other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ
• any unresolved CTC grade 2 toxicity from previous anticancer therapy (except alopecia)
• absolute neutrophil count less than 1.5 x 1,000,000,000 per liter
• platelets less than 20 x 1,000,000,000 per liter
• severe uncontrolled systemic disease
• pregnancy\breastfeeding
• women who are fertile and not willing to practice abstinence or contraception
• use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort
• treatment with a non-approved or investigational drug within 28 days before Day 1 of study treatment
• prior use of ZD1839 (Iressa) or any other anti-EGFR therapies