Breast Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with
temozolomide and to see how well it works in treating patients with breast cancer who have
received previous treatment for brain metastases.
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.
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