Xeloda (Capecitabine) and External Beam Radiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916578
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 study treatment will also be studied.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation Therapy Drug: Capecitabine Phase 2

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, you will receive radiation therapy once or twice a day, 5 days a week, for about 5 -7 weeks. The schedule and number of weeks will be the doctor's decision based on the type of breast cancer.

The radiation treatments will take about 15-30 minutes each time.

You will take the Capecitabine pills by mouth every day during the 5-7 weeks that you receive radiation therapy. The pills should be taken 2 times a day, about 12 hours apart, 30 minutes after eating food. On the radiation therapy days, you will take capecitabine about 2 hours before the radiation therapy.

You will be given a pill diary in which you should record what time you take each dose of capecitabine.

Study Visits:

Once a week while you are receiving study treatment, you will have a physical exam.

Length of Study:

You may remain on study treatment for up to 7 weeks. You will be taken off study treatment early if the disease gets worse or intolerable side effects occur.

Based on the status of the cancer, if you become eligible to have surgery after radiation, you will be referred to a surgeon to discuss that option.

Follow-Up Visits:

At Month 3 after finishing radiation therapy (or surgery, if applicable), you will have a positron emission tomography / computed tomography (PET/CT) scan or ultrasound to check the status of the disease.

At Months 9, 17, and 29 after finishing radiation therapy or surgery, you may have a PET/CT scan, ultrasound, and/or routine blood tests if your doctor thinks it is needed. The amount of blood drawn, if any, will be the doctor's decision based on routine care.

This is an investigational study. Capecitabine is commercially available and FDA approved to treat breast cancer that has spread. Radiation therapy is also commonly used to treat breast cancer. The combination of capecitabine and radiation therapy is commonly used to treat rectal cancer.

At this time, it is considered investigational to give the combination of capecitabine and radiation therapy to patients with breast cancer.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Inflammatory or Non-Inflammatory Breast Cancer
Actual Study Start Date : June 5, 2009
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Radiation Therapy + Capecitabine

Capecitabine 825 mg/m2 twice a day. One of the two daily doses of capecitabine should be taken approximately 2 hours before receiving radiotherapy. The first day of Capecitabine is same day that radiotherapy is started, and last day that Capecitabine is given is last day of radiotherapy. Capecitabine administered only on days patient receives radiation therapy.

Radiation therapy dose 50-57 Gy to initial clinical target volume (CTV, gross disease + tissue at risk for micrometastatic disease including margin around gross disease and draining regional lymphatics).

Radiation: Radiation Therapy
50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.
Other Names:
  • RT
  • Radiotherapy
Drug: Capecitabine
During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.
Other Name: Xeloda

Primary Outcome Measures :
  1. Tumor Response (complete response + partial response) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Assessed 4 weeks (+/- 4 days) after the last scheduled day of radiation ]
    Tumor responses according to RECIST. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histological confirmation of invasive breast cancer
  2. 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)
  3. 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).
  4. Are able to swallow and retain oral medication (intact pill)
  5. Age over 18
  6. Female gender

Exclusion Criteria:

  1. Have an active or uncontrolled infection
  2. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  3. Have used an investigational drug within 21 days preceding the first dose of study medication
  4. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)
  5. Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam
  6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00916578

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Wendy Woodward, MD, PHD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00916578     History of Changes
Other Study ID Numbers: 2009-0087
NCI-2012-01266 ( Registry Identifier: NCI CTRP )
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Inflammatory Breast Cancer
Non-Inflammatory Breast Cancer
Concomitant Radiation
Radiation Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents