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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Anastrozole; Gefitinib

Criteria

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