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
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
Secondary
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.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain
Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following:
Disease progression in the CNS must meet ≥ 1 of the following criteria:
New or progressive lesions that do not meet measurable disease definition allowed
Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases
Not a candidate for surgical resection and/or further stereotactic radiosurgery
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Menopausal status not specified
ECOG performance status 0-2
Life expectancy ≥ 1 month
Hemoglobin ≥ 10 g/dL (transfusion allowed)
ANC ≥ 1,500/mm³
Granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 mg/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
Must be able to swallow and retain oral medications
No other active malignancy except for any of the following:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast
No other known contraindication to MRI including, but not limited to, any of the following:
No active or uncontrolled infection
PRIOR CONCURRENT THERAPY: