Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery

• Status: Withdrawn
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Metformin

Criteria

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

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• 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

• Hemoglobin (Hg)A1C must be below 7%

• Total bilirubin less than 1.5 X institutional upper limit of normal

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 X institutional upper limit of normal

• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [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