Clinical trialPhase 1Withdrawn
Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
A Pharmacodynamic Study of Metformin in Patients With Resectable Pancreatic Cancer
- Outcome
- Stopped earlySlow accrual (Enrollment)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- January 2014
- Expected end
- March 2015
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Pancreatic tumor cell proliferation and apoptosis as measured by the percentage of cells Ki-67+, percentage of cells TUNEL+, and mitotic counts in tissue samples
- Sponsor
- Other
- Results posted
- No
- Last update
- 15 July 2015
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.