A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Carolyn Krasner, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|