Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer
This study tests the combination of two targeted therapies,along with chemotherapy treatment in the treatment of pancreatic cancer.
Until very recently, additional therapies in pancreatic cancer have targeted either the
vascular endothelial growth factor (VEGF) or epidermal growth factor (EGF) pathways, a
strategy which has shown variable clinical efficacy. This inconsistency is not surprising,
given the knowledge that tumors have a certain level of signal redundancy which may limit
the effectiveness of any one single-targeted therapy. The dual blockade of the EGF and VEGF
pathways takes aim at two of the most active cascades in tumorigenesis. Preliminarily, a
phase II study done in pancreatic cancer with gemcitabine, bevacizumab and erlotinib or
cetuximab has shown promising results and will most likely proceed to phase III study for
definitive efficacy assessment (Kindler et al, 2006).
In this study, targeted blockade is carried one step further with the inhibition of the
signaling cascade downstream of receptor tyrosine kinases at the level of raf. Given the
fact that the majority of pancreatic tumors display constitutive activation of the
Ras/Raf/MEK/ERK pathway, it is hoped that the addition of sorafenib to gemcitabine and
erlotinib will obtain a more complete blockade of the signal transduction cascade
responsible for pancreatic tumor growth and progression.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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