To carry out exploratory studies to determine if activity of this regimen correlates with
tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate
with activity of this regimen and provide exploratory insights in to the mechanism of this
treatment approach.
Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK
and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27
and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be
performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment,
and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be
submitted in place of the pre-treatment biopsy.