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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Once a week subcutaneous injection for 21 days, beginning at 180 mcg per week. Repeated for additional 21 days to begin at the same time as repeat 21 day Capecitabine cycle.
1000 mg/m\^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States
Neurologic progression-free survival rate at 6 months
Time frame: 6 months
Time to neurologic progression
Time frame: 6 months or until disease progression
Overall survival
Time frame: Up to 2 years
Tumor response (complete response and partial response)
Response Evaluation Criteria in Solid Tumors (RECIST) criteria for Target (Brain Metastasis) Lesions where Complete Response (CR): Disappearance of all target lesions; and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: 6 months
Toxicity
Toxicity defined as grade 3 or 4 hematologic, skin (hand and foot syndrome), or fatigue/myalgia/flu debilitation-syndrome (interferon-related) toxicities.
Time frame: 6 months
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