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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma

In brief

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

Key facts

Study ID

NCT00181688

Run by

Massachusetts General Hospital

People needed

35

Starts

2003-10-01

Expected to finish

2006-03-01

Last updated by the study team

2012-12-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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