Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
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.
Biological: PEG-interferon alfa-2a
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma|
- Neurologic progression-free survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Time to neurologic progression [ Time Frame: 6 months or until disease progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Tumor response (complete response and partial response) [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Toxicity defined as grade 3 or 4 hematologic, skin (hand and foot syndrome), or fatigue/myalgia/flu debilitation-syndrome (interferon-related) toxicities.
|Study Start Date:||September 2005|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine + PEG-interferon alfa-2a
Capecitabine 1000 mg/m2 orally twice daily during the first 14 days of each 3-week cycle (2 weeks on, 1 week rest), and PEG-interferon alfa-2a subcutaneously beginning at 180 mcg per week for 21 days.
Biological: PEG-interferon alfa-2a
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.
Other Names:Drug: Capecitabine
1000 mg/m^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).
Other Name: Xeloda
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227656
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65807|
|United States, Texas|
|University of Texas M.D. Anderson CCOP Research Base|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Morris D. Groves, MD, JD||M.D. Anderson Cancer Center|