Brain Mets - Capecitabine and WBRT

This study has been terminated.
(Due to poor accrual this study is being closed to accrual)
Sponsor:
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00570908
First received: December 7, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: sunitinib
Drug: capecitabine
Radiation: WBRT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • Progression free survival 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity by grades according to v3.0 (CTCAE). intervals. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: February 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
capecitabine concurrently with WBRT followed by combination capecitabine with sunitinib
Drug: sunitinib
Sutent
Other Name: sunitinib
Drug: capecitabine
concurrently
Other Name: capecitabine
Radiation: WBRT
Whole Brain Radiotherapy 30 Gy in 10 fractions
Other Name: Whole Brain Radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed inform consent.
  2. Patients must be age 18 or older.
  3. Histological or cytologically confirmed invasive breast cancer, with Stage IV disease.
  4. Patient must have 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.
  5. All patients 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.
  6. No prior whole brain radiation.
  7. 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.
  8. Patients may undergo surgical resection of CNS metastases if clinically indicated, but must have remaining measurable disease in the brain after surgery.
  9. 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.
  10. Patients who had previous trastuzumab therapy will be eligible but treatment will be discontinued prior to enrollment.
  11. Cardiac ejection fraction within institutional range of normal as measure by echocardiogram or MUGA scans at baseline.
  12. Hematological adequacy as indicated by:

    • ANC greater than or equal to 1000mg/mm3
    • Hemoglobin greater than or equal to 9gm/dL
    • Platelets greater than or equal to 50,000/mm3.
  13. Hepatic adequacy as indicated by:

    • Bilirubin less than or equal to 2.0 times upper limit of normal
    • AST and ALT less than or equal to 5 times upper limit of normal.
  14. Renal adequacy as indicated by:

    • Creatinine less than or equal to 1.5 times upper limit of normal
  15. Patients must have recovered from toxicity of prior chemotherapy with laboratory values as specified above. Concurrent treatment with bisphosphonates is permitted.
  16. Performance status of ECOG 0-1.
  17. Life expectancy of at least 12 weeks.
  18. At least 3 weeks since major surgical procedures.
  19. Able to swallow and retain oral medication.

Exclusion Criteria:

  1. Patients who are pregnant or breast feeding.
  2. Known allergy to capecitabine or 5-fluorouracil.
  3. Known to have dihydropyrimidine dehydrogenase (DPD) deficiency.
  4. Patients who have leptomeningeal carcinomatosis as the only site of CNS metastases.
  5. Patients taking concomitant medications which are CYP3A4 inhibitors or inducers.
  6. Patients who will receive intrathecal chemotherapy for leptomeningeal disease.
  7. Patients with psychiatric or addictive disorders that would adversely effect compliance with oral medication.
  8. Life expectancy less than 3 months.
  9. Patients with symptomatic lymphangitic spread to lung.
  10. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
  11. History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents, or other contraindication or gadolinium contrast.
  12. Other known contraindication to MRI, such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel,
  13. Vascular disease within 12 months prior to enrollment, defined as one or more of the following:

    • history of documented myocardial infarction (including severe/unstable angina)
    • Coronary/peripheral artery bypass graft
    • Symptomatic heart failure (CHF)
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism,
  14. Uncontrolled infection
  15. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570908

Locations
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
Investigators
Principal Investigator: Mothaffar` Rimawi, MD Baylor College of Medicine, Breast Center
  More Information

No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00570908     History of Changes
Other Study ID Numbers: H-20924, Brain Mets Radiation Study
Study First Received: December 7, 2007
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
brain metastasis
breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 21, 2014