Clinical trial NCT01877564: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Endometrium
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: IHC-based Tissue Markers of Proliferation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References: