Pancreatic Cancer Clinical Trial
Official title:
Phase I Study of Gemcitabine With Novel RAF Kinase-Vascular Endothelial Growth Factor Receptor Inhibitor Sorafenib (BAY 43-9006) and Radiotherapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the safety and tolerability of the combined treatment of Sorafenib (BAY 43-9006) with Gemcitabine and radiotherapy in patients with localized unresectable pancreatic cancer.
Pancreatic cancer treatment is hampered by its resistance to both chemo and radiotherapy.
Gemcitabine-based chemoradiotherapy has become one of the standard therapies for localized
unresectable pancreatic cancer, but with poor responses and survival rates of less than 12
months. Radiotherapy increases VEGF expression and activates the Ras/MEK/ERK pathway which
may contribute to radioresistance, thus the addition of anti-angiogenic agents and/or
Ras/ERK inhibitors could enhance radiation mediated cytotoxicity. Sorafenib is a novel
dual-action Raf kinase and vascular endothelial growth factor receptors (VEGF-R2 and
VEGF-R3) inhibitor targeting both angiogenic and Ras-Raf-1 signal transduction pathways.
Based upon preliminary laboratory and clinical data Sorafenib holds promise for improving
outcomes of therapy for patients with locally advanced unresectable pancreatic cancer.
Polymorphisms in genes involved in the angiogenesis pathway (VEGF, VEGF-R2, HIF-1 and eNOS)
may contribute to the process of angiogenesis, tumor behavior, and may explain the
heterogeneity in efficacy (and toxicity) of agents whose major mechanism of action is
blocking angiogenesis33-37. Proteomic analysis may also contribute to identify patterns of
response or resistance to therapies, and potentially predict outcomes.
Dynamic contrast enhanced (DCE)-MRI has been shown to be a useful pharmacodynamic marker of
biological activity for anti-angiogenic agents38-40 and may also predict radiation
therapy-induced vascular changes41. In vivo imaging of angiogenesis using DCE-MRI and the
analysis of angiogenesis markers genetic polymorphisms may predict response and clinical
benefit to therapy for unresectable pancreatic cancer patients. These biologic and
pharmacodynamic endpoints will be analysed to correlate with the tumor activity seen.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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