Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

Completed · Phase 2 · Has a placebo group

Conditions studied: Barrett Esophagus, Esophageal Cancer

In brief

This randomized phase II trial studies how well metformin hydrochloride works in preventing esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal cancer from forming.

Key facts

Study ID

NCT01447927

Run by

National Cancer Institute (NCI)

People needed

93

Starts

2012-06-01

Expected to finish

2013-09-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of Barrett esophagus, with no dysplasia, indeterminate for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and >= 2 cm of involvement on endoscopy
• Adequate Barrett mucosa, which is defined as >= 1 out of 4 research samples (i.e., >= 25%) with >= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study
• No history of esophageal carcinoma or other cancer(s) (except for non-melanoma skin cancers)
• No erosive esophagitis or ulcerative esophagitis, unless treatment with a proton pump inhibitor (PPI) results in healed erosions or ulcers prior to entry endoscopy
• No history of high-grade dysplasia or cancer (confirmed locally by esophagogastroduodenoscopy [EGD] and Pathology reports)
• No ulcer, plaque, nodule, stricture, or other luminal irregularity within the Barrett segment, unless clinical biopsy produces no evidence of high-grade dysplasia or cancer
• ECOG performance status =< 1
• Hemoglobin >= 10 g/dL
• Leukocytes >= 3,000/mL (>= 2,500/mL for African-American participants)
• Absolute neutrophil count >= 1,500/mL (>= 1,000/mL for African-American participants)
• Platelets >= 100,000/mL
• Total bilirubin =< institutional upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) =< 1.5 times institutional ULN
• Creatinine =< institutional ULN
• Willingness to provide tissue samples for research purposes
• No contraindication to esophagogastroduodenoscopy (EGD)
• Willingness, for both men and women, to use adequate contraception (hormonal or barrier method of birth control; surgical intervention; abstinence) prior to study entry and for the duration of study participation
• A negative (serum or urine) pregnancy test done =< 7 days prior to Pre-Registration, for women of childbearing potential only
• No pregnant or nursing women
• No participants with diabetes mellitus
• No history of vitamin B12 deficiency or megaloblastic anemia
• No history of lactic acidosis
• No diseases associated with weight loss: anorexia, bulimia, or nausea
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
• No participants with HIV, cirrhosis of any cause, NASH (non-alcoholic steatohepatitis), or hepatitis (auto-immune or infectious)

Where it is running

• Hines Veterans Administration Hospital — Hines, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center - Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• University of Toronto — Toronto, Ontario, Canada
• University of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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