Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
- Conditions
- Breast CancerMetastatic Cancer
- Interventions
- Biological: PEG-interferon alfa-2a
- Registration Number
- NCT00227656
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine + PEG-interferon alfa-2a 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. Capecitabine + PEG-interferon alfa-2a Capecitabine 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.
- Primary Outcome Measures
Name Time Method Neurologic progression-free survival rate at 6 months 6 months
- Secondary Outcome Measures
Name Time Method Time to neurologic progression 6 months or until disease progression Overall survival Up to 2 years Tumor response (complete response and partial response) 6 months 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 6 months Toxicity defined as grade 3 or 4 hematologic, skin (hand and foot syndrome), or fatigue/myalgia/flu debilitation-syndrome (interferon-related) toxicities.
Trial Locations
- Locations (4)
University of Texas M.D. Anderson CCOP Research Base
🇺🇸Houston, Texas, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States