Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This is a phase II clinical trial to assess the efficacy of the combination of metronomic
cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly
vascular tumors, and high VEGF expression has been correlated with worse clinical and
pathological characteristics as well as poor prognosis. A novel antiangiogenic approach
relies on targeting not only the endothelial cells but also rendering them more sensitive to
VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will be
titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel
pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients'
peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering
sorafenib plus metronomic low dose cyclophosphamide.