The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
Official Title: A Pharmacodynamic Study of Metformin in Patients With Resectable Pancreatic Cancer
Study ID: NCT01954732
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Jennifer Eads, MD
Affiliation: Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR