Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227656
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2005-09-26
Brief Title:
Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Capecitabine Xeloda and Pegylated Interferon Alfa-2APegasys for Recurrent or Progressive Brain Metastasis From Breast Carcinoma
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study slow to accrue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000443592 | OTHER | NCI | None |
| MDA-2004-0727 | None | None | None |
| NCI-6810 | None | None | None |