Spots Global Cancer Trial Database for Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors
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Trial Identification
Brief Title: Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors
Official Title: Tailored-dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment
Study ID: NCT00605566
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Lillian Siu, MD
Affiliation: University Health Network, Toronto
Role: PRINCIPAL_INVESTIGATOR
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