Well-differentiated Neuroendocrine Tumors Clinical Trial
Official title:
A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence.
The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has
demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in
preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may
be an alternative treatment for this disease.
Eligible patients for this study should have metastatic gastroenteropancreatic
neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with
metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of
treatment the efficacy of metformin under the control of disease progression will be
evaluated. As a secondary outcome the investigator will check the patient adherence to the
treatment, the control of patient symptoms with functioning neuroendocrine tumor, and
disease free survival. Also will be performed an analysis of immunohistochemical expression
of mTOR pathway proteins of these patients.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment