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

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Tubal Carcinoma

Ovarian Cancer

Peritoneal Carcinoma

Treatments

Drug: Arimidex (Anastrozole)

Drug: Iressa (ZD1839)

Study type

Interventional

Funder types

Other

Identifiers

03-250

Details and patient eligibility

About

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

Full description

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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