Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00227656|
Recruitment Status : Terminated (Study slow to accrue.)
First Posted : September 28, 2005
Last Update Posted : December 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Biological: PEG-interferon alfa-2a Drug: Capecitabine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Capecitabine (Xeloda®) and Pegylated Interferon Alfa-2A(Pegasys®) for Recurrent or Progressive Brain Metastasis From Breast Carcinoma|
|Study Start Date :||September 2005|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
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
- 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) [ Time Frame: 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 [ Time Frame: 6 months ]Toxicity defined as grade 3 or 4 hematologic, skin (hand and foot syndrome), or fatigue/myalgia/flu debilitation-syndrome (interferon-related) toxicities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|