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Brain Mets - Capecitabine Plus Sunitinib and WBRT

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: NCT00570908
Recruitment Status : Terminated (Due to poor accrual this study is being closed to accrual)
First Posted : December 11, 2007
Results First Posted : August 12, 2014
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Baylor Breast Care Center

Brief Summary:
The purpose of this study is to assess the efficacy and safety of concurrent whole brain radiotherapy (WBRT) and capecitabine followed by combination capecitabine and sunitinib in treating patients with CNS metastases from breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: sunitinib Drug: capecitabine Radiation: WBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Capecitabine Concomitantly With Whole Brain Radiotherapy(WBRT) Followed by Capecitabine and Sunitinib for Central Nervous System, (CNS) Metastases in Breast Cancer
Study Start Date : February 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Study Group
capecitabine administered concurrently with WBRT followed by combination the combination of capecitabine with sunitinib
Drug: sunitinib

Drug: capecitabine

Radiation: WBRT
Whole Brain Radiotherapy 30 Gy in 10 fractions
Other Name: Whole Brain Radiotherapy

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.

Information from the National Library of Medicine

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

Inclusion Criteria:

Patients must be age 18 or older. Histological or cytologically confirmed invasive breast cancer, with Stage IV disease.

Evidence of radiographically measurable CNS metastases (greater than or equal to 10mm on T1-weighted gadolinium-enhanced MRI) within 2 weeks prior to starting treatment. Patients without known extra-CNS disease are eligible.

Must have metastases in the brain. Patients with concurrent leptomeningeal carcinomatosis are eligible for the study. Local radiation to sites of meningeal involvement in the spine is allowed.

No prior whole brain radiation. Patients who had previous stereotactic brain irradiation are eligible, provided they have new measurable brain lesions (which has not been radiated previously) and will receive WBRT at 30Gy over 10 fractions.

May undergo surgical resection of CNS metastases if clinically indicated, but must have remaining measurable disease in the brain after surgery.

No prior treatment with capecitabine in the adjuvant or metastatic settings. Patients may have completed 5-fluorouracil based treatment in the adjuvant setting or metastatic setting more than one year prior.

Patients who had previous trastuzumab therapy will be eligible but treatment will be discontinued prior to enrollment.

Cardiac ejection fraction within institutional range of normal as measure by echocardiogram or MUGA scans at baseline.

Hematological adequacy Hepatic adequacy Renal adequacy Must have recovered from toxicity of prior chemotherapy with laboratory values as specified above. Concurrent treatment with bisphosphonates is permitted. Performance status of ECOG 0-1.

Life expectancy of at least 12 weeks. At least 3 weeks since major surgical procedures. Able to swallow and retain oral medication.

Exclusion Criteria:

Pregnant or breast feeding. Known allergy to capecitabine or 5-fluorouracil. Known to have dihydropyrimidine dehydrogenase (DPD) deficiency.

Patients who have leptomeningeal carcinomatosis as the only site of CNS metastases.

Patients taking concomitant medications which are CYP3A4 inhibitors or inducers.

Patients who will receive intrathecal chemotherapy for leptomeningeal disease. Patients with psychiatric or addictive disorders that would adversely effect compliance with oral medication.

Life expectancy less than 3 months. Symptomatic lymphangitic spread to lung. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.

History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication or gadolinium contrast.

Other known contraindication to MRI, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel,

1Vascular disease within 12 months prior to enrollment Uncontrolled infection History of other malignancy, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with other malignancies who have been disease-free for at least 5 years are eligible

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): NCT00570908

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United States, Texas
Lester and Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
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Principal Investigator: Mothaffar` Rimawi, MD Baylor College of Medicine, Breast Center

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Responsible Party: Baylor Breast Care Center Identifier: NCT00570908    
Other Study ID Numbers: H-20924
H 20924 ( Other Identifier: Baylor College of Medicine )
First Posted: December 11, 2007    Key Record Dates
Results First Posted: August 12, 2014
Last Update Posted: September 18, 2014
Last Verified: August 2014
Keywords provided by Baylor Breast Care Center:
brain metastasis
breast cancer
metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors