Status:
COMPLETED
Xeloda (Capecitabine) and External Beam Radiation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to find out if Xeloda® (capecitabine) and radiation therapy can help to control breast cancer that did not respond well to chemotherapy. The safety of this...
Detailed Description
The Study Treatment: Radiation therapy and capecitabine are both designed to interfere with the growth of cancer cells. Study Therapy: If you are found to be eligible to take part in this study, yo...
Eligibility Criteria
Inclusion
- Histological confirmation of invasive breast cancer
- No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication)
- Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast).
- Are able to swallow and retain oral medication (intact pill)
- Age over 18
- Female gender
Exclusion
- Have an active or uncontrolled infection
- Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Have used an investigational drug within 21 days preceding the first dose of study medication
- Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)
- Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam
- Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
Key Trial Info
Start Date :
June 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00916578
Start Date
June 5 2009
End Date
June 6 2017
Last Update
July 26 2018
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030