NCT01877564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

June 11, 2013

Results QC Date

August 9, 2017

Last Update Submit

September 25, 2017

Conditions

Adenocarcinoma of the Endometrium

Outcome Measures

Primary Outcomes (1)

  • IHC-based Tissue Markers of Proliferation

    1 year

Study Arms (2)

Group 1 - Metformin

EXPERIMENTAL

oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Drug: Metformin

Group 2 - No treatment

NO INTERVENTION

Interventions

MetforminDRUG
Group 1 - Metformin

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Beth Scanlan
Organization
University of Arkansas for Medical Sciences
BScanlan@uams.edu
5016868274

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

August 29, 2013

Primary Completion

August 10, 2016

Study Completion

July 10, 2017

Last Updated

October 25, 2017

Results First Posted

October 25, 2017

Record last verified: 2017-09

Locations

US(1)