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
OBJECTIVES:
Primary
- 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
metastases.
- To determine the toxicities associated with the combination of irinotecan hydrochloride
and temozolomide in breast cancer patients with progressive brain metastases.
Secondary
- 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
unacceptable toxicity.
After completion of study therapy, patients are followed every 4 weeks.
Interventional
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
No
Michelle Melisko, MD
Principal Investigator
University of California, San Francisco
United States: Food and Drug Administration
CDR0000583265
NCT00617539
February 2005
December 2014
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |