Stage IIB Pancreatic Cancer Clinical Trial
Official title:
A Pharmacodynamic Study of Metformin in Patients With Resectable Pancreatic Cancer
This randomized clinical trial studies metformin hydrochloride in treating patients with pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the effect of escalating doses of metformin (metformin hydrochloride) given
pre-operatively on pancreatic cancer cell proliferation and apoptosis.
SECONDARY OBJECTIVES:
I. To assess toxicity of escalating doses of metformin given pre-operatively in patients
with resectable pancreatic carcinoma.
II. To measure the effect of metformin on the expression of phosphorylated acetyl-CoA
carboxylase alpha (ACC), phosphorylated mechanistic target of rapamycin (serine/threonine
kinase) (mTOR), and pancreatic cancer stem cells.
OUTLINE: Patients are randomized to 1 of 3 treatment groups.
GROUP I: Patients undergo observation.
GROUP II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) for at
least 7 days in the absence of disease progression or unacceptable toxicity.
GROUP III: Patients receive metformin hydrochloride as in Group II.
After completion of study treatment, patients are followed up 30 days.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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