50
Participants
Start Date
August 31, 2002
Primary Completion Date
October 31, 2007
Study Completion Date
October 31, 2007
erlotinib hydrochloride
Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
TUNEL assay
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
protein expression analysis
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
immunohistochemistry staining method
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
laboratory biomarker analysis
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
liquid chromatography
Used to determine blood plasma levels of Erlotinib on the day of surgery
mass spectrometry
Used to determine blood plasma levels of Erlotinib on the day of surgery
matrix-assisted laser desorption ionization mass spectrometry
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
therapeutic conventional surgery
Surgical treatment will occur within 24-hours following completion of therapy.
Lineberger Comprehensive Cancer Center, Chapel Hill
University of Alabama, Birmingham, Birmingham
Meharry Medical College, Nashville
Vanderbilt-Ingram Cancer Center, Nashville
Dana-Farber Cancer Institute, Boston
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER