A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER
- To determine the response rate, as assessed by RECIST criteria, in patients with
recurrent locally advanced or metastatic breast cancer treated with irinotecan
hydrochloride and etoposide after prior exposure to anthracycline, taxane, and
- To determine the median time to progression in these patients.
- To determine the response duration and survival in these patients.
- To measure the type and rate of grade 3 or greater toxicity of this treatment regimen
in these patients.
OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on
days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted
After completion of study therapy, patients are followed every 3 months for 3 years, every 6
months for 2 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response (complete and partial response) rate as assessed by RECIST criteria
Every eight weeks
Robert B. Livingston, MD
University of Arizona
United States: Food and Drug Administration
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|