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
basis.
Interventional
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
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
03-250
NCT00181688
October 2003
March 2006
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |