Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title A Pharmacodynamic Study of Metformin in Patients with Resectable Pancreatic Cancer
IRB CASE 1213
CC 041322C
Hospital Main Campus
Disease Pancreas
Drug Metformin
Description
Primary- To determine the effect of escalating doses of metformin given pre-operatively on pancreatic cancer cell proliferation and apoptosis.
- To assess toxicity of escalating doses of metformin given pre-operatively in patients with resectable pancreatic carcinoma.
- To measure the effect of metformin on the expression of phosphorylated ACC, phosphorylated mTOR, and pancreatic cancer stem cells.
Inclusion Criteria
- Patients must have histologically or cytologically confirmed resectable pancreatic carcinoma. Patients with pancreatic neuroendocrine tumors are not eligible.
- Patients must be previously untreated with chemotherapy or radiation therapy
- Age ≥ 18 years.
- ECOG Performance status ≤ 2 (see Appendix A)
- Patients must have surgical resection of the pancreas planned, with enrollment at least 7 days prior to surgery. Patients with surgery scheduled > 15 days will not be excluded.
- HgA1C must be below 7%
- Patients must have acceptable organ function as defined below:
- Total bilirubin less than 1.5 X institutional upper limit of normal
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Serum Creatinine within normal institutional limits
- Alkaline Phosphatase < 1.5 X institutional upper limit of normal
- Subjects must have the ability to understand and be willing to provide written informed consent.
Exclusion Criteria
- History of metformin use in the previous 3 months
- Treatment with neoadjuvant chemotherapy or radiation therapy.
- History of allergic reactions attributed to metformin
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Metabolic acidosis, acute or chronic, including ketoacidosis
- Metastatic disease