A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women

University of Arkansas1 site in 1 country10 target enrollmentAugust 29, 2013

ConditionsAdenocarcinoma of the Endometrium

InterventionsMetformin

DrugsMetformin

Overview

Phase: Phase 2
Intervention: Metformin
Conditions: Adenocarcinoma of the Endometrium
Sponsor: University of Arkansas
Enrollment: 10
Locations: 1
Primary Endpoint: IHC-based Tissue Markers of Proliferation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.

Registry

clinicaltrials.gov

Start Date

August 29, 2013

End Date

July 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Arkansas

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
•Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
•Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
•Subjects must have signed informed consent
•Age 42 - 65 years of age
•Electrocorticogram (ECOG) Performance status of 0 - 2
•History of adequate renal, liver, and bone marrow function:
•Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range)
•Platelets: (180K/cmm)
•Liver Function Test(LFTs): Normal bilirubin (\<2.0mg/dL), AST/ALT (2xULN)

Exclusion Criteria

•Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma
•History of diabetes mellitus Type 1 or Type
•Receiving metformin prior to enrollment
•Known hypersensitivity to metformin.
•Unable to swallow and retain oral medication.
•Pregnant or lactating.
•Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for \> 5 years
•If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
•Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
•Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.