Xeloda (Capecitabine) and External Beam Radiation

NCT ID: NCT00916578

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-05
• Study Completion Date: 2017-06-06

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

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.

Capecitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Other Intervention Names

RT; Radiotherapy; Xeloda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Woodward, MD, PHD

Role: STUDY_CHAIR

UT MD Anderson Cancer Center

Locations

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2012-01266

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-0087

Identifier Type: -

Identifier Source: org_study_id