Status:
COMPLETED
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
Lead Sponsor:
University of Arkansas
Conditions:
Adenocarcinoma of the Endometrium
Eligibility:
FEMALE
45-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01877564
Start Date
August 29 2013
End Date
July 10 2017
Last Update
October 25 2017
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205