Xeloda (Capecitabine) and External Beam Radiation
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
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 study treatment will also be studied.
Key facts
- Study ID
- NCT00916578
- Run by
- M.D. Anderson Cancer Center
- People needed
- 33
- Starts
- 2009-06-05
- Expected to finish
- 2017-06-06
- Last updated by the study team
- 2018-07-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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