Capecitabine and Pegylated Interferon Alfa-2a in Treating Patients With Recurrent or Progressive Brain Metastases Due to Breast Cancer

NCT00227656 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-12-11

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Capecitabine

1000 mg/m\^2 twice daily during first 14 days of each 3-week cycle (2 weeks on, 1 week rest).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Morris D. Groves, MD, JD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00227656 on ClinicalTrials.gov