Brain Mets - Capecitabine and WBRT
This study is currently recruiting participants.
Verified July 2013 by Baylor Breast Care Center
Information provided by (Responsible Party):
Baylor Breast Care Center
First received: December 7, 2007
Last updated: July 23, 2013
Last verified: July 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Active Comparator: 1
capecitabine concurrently with WBRT followed by combination capecitabine with sunitinib
Other Name: sunitinib
Other Name: capecitabine
Whole Brain Radiotherapy 30 Gy in 10 fractions
Other Name: Whole Brain Radiotherapy
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed inform consent.
- Patients must be age 18 or older.
- Histological or cytologically confirmed invasive breast cancer, with Stage IV disease.
- 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.
- 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.
- 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.
- Patients 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 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.
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.
Renal adequacy as indicated by:
- Creatinine less than or equal to 1.5 times upper limit of normal
- Patients 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.
- Patients who are 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.
- Patients with 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,
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,
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570908
|Lester and Sue Smith Breast Center at Baylor College of Medicine
|Houston, Texas, United States, 77030 |
|Contact: Ashley Whittington, BS 713-798-1986 firstname.lastname@example.org |
|Contact: Anne Pavlick, BS 713-798-1986 email@example.com |
Baylor Breast Care Center
||Mothaffar` Rimawi, MD
||Baylor College of Medicine, Breast Center
No publications provided
||Baylor Breast Care Center
History of Changes
|Other Study ID Numbers:
||H-20924, Brain Mets Radiation Study
|Study First Received:
||December 7, 2007
||July 23, 2013
||United States: Food and Drug Administration
Keywords provided by Baylor Breast Care Center:
metastatic breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiogenesis Modulating Agents