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

NCT ID: NCT01954732

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I (observation)

Patients undergo observation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group II (metformin hydrochloride)

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

Group Type: EXPERIMENTAL

metformin hydrochloride

Intervention Type: DRUG

Given PO

pharmacological study

Intervention Type: OTHER

Correlative studies

Group III (metformin hydrochloride)

Patients receive metformin hydrochloride as in Group II.

Group Type: EXPERIMENTAL

metformin hydrochloride

Intervention Type: DRUG

Given PO

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

metformin hydrochloride

Given PO

Intervention Type: DRUG

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Glucophage; pharmacological studies

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Eads, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Other Identifiers

NCI-2013-01836

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE 1213

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE1213

Identifier Type: -

Identifier Source: org_study_id