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

NCT01954732 | Withdrawn Phase 1 DMC

• 4 other identifiers: CASE1213NCI-2013-01836CASE 1213P30CA043703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  The difference between treatment groups will be compared using analysis of variance (ANOVA) (3 groups) followed by Tukey's pair-wise comparison procedure. Transformation may be applied (e.g. natural log) prior to analysis to better approximate normality.

  At time of surgery (after 7 days of treatment)

Secondary Outcomes (3)

• Occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0)

  Baseline to 30 days after treatment has been discontinued or after the date of surgery, whichever occurs first

• Expression of pACC and pMTOR quantified by the mean fluorescence intensity (MFI) in tissue samples

  At time of surgery (after 7 days of treatment)

• Percentage of pancreatic cancer stem cells in tissue samples

  At time of surgery (after 7 days of treatment)

Study Arms (3)

Group I (observation)

NO INTERVENTION

Patients undergo observation.

Group II (metformin hydrochloride)

EXPERIMENTAL

Patients receive metformin hydrochloride PO BID for at least 7 days in the absence of disease progression or unacceptable toxicity.

Drug: metformin hydrochloride; Other: pharmacological study

Group III (metformin hydrochloride)

EXPERIMENTAL

Patients receive metformin hydrochloride as in Group II.

Drug: metformin hydrochloride; Other: pharmacological study

Interventions

metformin hydrochloride DRUG

Given PO

Also known as: Glucophage

Group II (metformin hydrochloride); Group III (metformin hydrochloride)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Group II (metformin hydrochloride); Group III (metformin hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jennifer Eads, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07