Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

• Patients will receive Iressa and anastrozole orally once daily until treatment is ended. Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression.
• Patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications.
• Patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.

Inclusion criteria

• Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma
• Asymptomatic from ovarian cancer
• Evidence of recurrent ovarian, peritoneal or tubal carcinoma
• Tumor sample must be positive for ER and/or PR
• 18 years of age or older
• ECOG performance status of less than or equal to 1
• Must be able to tolerate oral intake

Exclusion criteria

• Known hypersensitivity to Iressa or any of the excipients of this product
• Other coexisting malignancies or malignancies diagnosed within the last 5 years
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort
• Treatment with a non-approved or investigational drug within 30 days
• Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia)
• Incomplete healing from previous oncologic or other major surgery
• Serum creatinine level greater than CTC grade 2
• Pregnant or breast feeding
• Severe uncontrolled systemic disease
• Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
• Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment
• Patients previously treated with anastrozole or other aromatase inhibitor
• Unable to tolerate oral medications
• Clinical and/or radiographic evidence of current or impending bowel obstruction