20
Participants
Start Date
April 30, 2006
Primary Completion Date
June 30, 2010
Study Completion Date
August 31, 2012
lapatinib ditosylate
Patients will be assigned in cohorts of 3. Dose levels of GW572106 will include 500mg, 1000mg,1500 mg (additional levels at 750 mg and 1250 mg will be added if needed). Lapatinib is an oral drug. It is taken every day.
TdT-mediated dUTP nick end labeling assay
Genetic analysis of tumor tissue
gene expression analysis
Genetic analysis of tumor tissue.
microarray analysis
Genetic analysis of tumor tissue.
immunohistochemistry staining method
Laboratory analysis of tumor tissue.
biopsy
Serial biopsies by skin punch or core biopsy or fine needle aspiration.
radiation therapy
Radiotherapy will be delivered at standard dose and fractionation. For patients who have not received previous locoregional radiotherapy, 50-56 Gy will be delivered to the regional lymph nodes and/or chest wall at a dose of 2 Gy per fraction, 5 days per week followed by a boost to the sites of gross involvement to a total dose of 60-70 Gy over a course of 6-7 weeks. For patients who have received adjuvant radiotherapy, a dose of 35-45 Gy will be delivered to sites of chest wall involvement at a dose of 1.8 Gy per fraction over 4-5 weeks. In either de novo or reirradiated settings, the total dose to the brachial plexus will not exceed 60 Gy.
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER