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

• Status: Completed
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Metformin

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)

• Renal function: creatinine less than 1.4

• Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

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 2.

• 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.

• History of lactic or other metabolic acidosis.

• Uncontrolled infectious disease.

• History of positivity for human immunodeficiency virus (HIV).

• History of congestive heart failure requiring pharmacologic treatment.

• History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.

• Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.

• Current use of medications for weight loss.

• Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.