Breast Cancer Clinical Trial
Official title:
Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Pegylated interferon alfa-2a may interfere with the growth of tumor cells. Giving
capecitabine together with pegylated interferon alfa-2a may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with
pegylated interferon alfa-2a works in treating patients with recurrent or progressive brain
metastases due to breast cancer.
OBJECTIVES:
Primary
- Determine the efficacy of capecitabine and pegylated interferon alfa-2a, in terms of
6-month neurologic progression-free rate, in patients with recurrent or progressive
brain metastases secondary to breast cancer.
Secondary
- Determine the toxicity spectrum of this regimen in these patients.
- Determine the time to neurologic progression and overall survival of patients treated
with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14 and pegylated interferon alfa-2a
subcutaneously on days 1, 8, and 15. Treatment repeats every 3 weeks for at least 6 months
in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 38-98 patients will be accrued for this study within 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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