A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation
- To evaluate the objective response rate systemically and in the CNS to the combination
of irinotecan hydrochloride and temozolomide among patients with breast cancer and
progressive brain metastases that have progressed after previous treatment for brain
- To determine the toxicities associated with the combination of irinotecan hydrochloride
and temozolomide in breast cancer patients with progressive brain metastases.
- To evaluate the time to first progression at any site (CNS or extra-CNS) in patients
treated with the combination of irinotecan hydrochloride and temozolomide.
- To evaluate the overall survival of patients treated with the combination of irinotecan
hydrochloride and temozolomide for brain metastases.
OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7
and 15-21. Treatment repeats every 28 days in the absence of disease progression or
After completion of study therapy, patients are followed every 4 weeks.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (percentage of patients with complete or partial response) in the CNS at ≥ 16 weeks
Michelle Melisko, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|