Brain Mets - Capecitabine Plus Sunitinib and WBRT

NCT00570908 | Terminated Phase 2 Results DMC

• 2 other identifiers: H-20924H 20924
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

brain metastasis; breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  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.

  2 years

Study Arms (1)

Study Group

EXPERIMENTAL

capecitabine administered concurrently with WBRT followed by combination the combination of capecitabine with sunitinib

Drug: sunitinib; Drug: capecitabine; Radiation: WBRT

Interventions

sunitinib DRUG

Sutent

Study Group

capecitabine DRUG

concurrently

Study Group

WBRT RADIATION

Whole Brain Radiotherapy 30 Gy in 10 fractions

Also known as: Whole Brain Radiotherapy

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Vascular 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

Sponsors & Collaborators

• Baylor Breast Care Center: lead

Study Sites (1)

Lester and Sue Smith Breast Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

Sunitinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Mothaffar Rimawi
• Organization: Baylor Coolege of Medicine

rimawi@bcm.edu

7137981811

Study Officials

• Mothaffar' Rimawi, MD

  Baylor College of Medicine, Breast Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: February 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 18, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-08

Locations

US (1)