Brief Title
Endometrial Cancer Biomarker Changes Following Exposure to Metformin
Official Title
A Clinical Trial to Evaluate Endometrial Cancer Biomarker Changes Following Exposure to the Insulin Sensitizer Metformin
Brief Summary
The investigators will explore the chemopreventive role of metformin. The purpose of this
study is to determine whether, among patients with endometrial cancer, treatment with the
currently approved insulin sensitizing drug metformin increases or decreases pathway
activation distal to the insulin receptor in endometrial cancer tissue. This is a phase IIa
study of metformin to be used to the pre-operative period of women diagnosed with endometrial
cancer by comparing their endometrial biopsy specimens taken at their initial visit and after
4-6 weeks of treatment of metformin on the day of their surgical staging.
Detailed Description
Aim 1 To determine whether, among patients with endometrial cancer, treatment with the
currently approved insulin sensitizing drug metformin increases or decreases pathway
activation distal to the insulin receptor in endometrial cancer tissue.
Aim II To compare specified biomarkers in each endometrial cancer patient before and after
receiving metformin. Our goal is to compare the following biomarkers in each patient before
and after metformin administration: Ki-67, TUNEL assay for apoptosis level, phosphor-AMPK,
phosphor-IGF-1R, phosphor-IRS1, phospho-Akt, phospho-S6, phosphor-mTOR, pACC.
All patients diagnosed with endometrial cancer presenting to the Jewish General Hospital for
surgical treatment will be invited to participate.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change in phosphorylated-S6
Secondary Outcome
Effects of metformin on activation pathways downstream of the insulin receptor in endometrial samples by testing Ki-67
Condition
Endometrial Cancer
Intervention
Metformin
Study Arms / Comparison Groups
Metformin
Description: Metformin 500 mg PO TID from time of entry to study until scheduled surgical staging operation. In cases of unresolving side effects, the metformin will be dose reduced to metformin 500 mg PO BID with evaluation after 1 week followed by withdrawal from the study if side effects persist.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
August 2016
Primary Completion Date
December 2017
Eligibility Criteria
Inclusion Criteria:
- Have a confirmed diagnosis of endometrial cancer based on an endometrial sampling
though biopsy or dilatation and curettage
- Must be able to undergo appropriate surgical staging for endometrial cancer
- Must consent to be in the study and must have signed and dated an IRB-approved consent
form conforming to government and institutional guidelines
Exclusion Criteria:
- Patients with a contraindication to receiving metformin treatment
- Patients with cognitive impairment
- Renal or hepatic functioning > 125% upper limit of normal
- Currently on medications for metabolic diseases, such as diabetes mellitus
- History of lactic acidosis
- Treatment with medications that may increase metformin levels: cationic drugs, e.g.,
digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine
- History of chronic alcohol abuse
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02042495
Organization ID
JGH-140111
Responsible Party
Principal Investigator
Study Sponsor
Jewish General Hospital
Study Sponsor
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Verification Date
August 2016