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Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer

NCT01205672 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-06-02

No results posted yet for this study

Summary

The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes.

Objectives:

Primary Objectives:

1\. To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in the endometrium of women with endometrial cancer

Secondary Objectives:

1. To describe the effects of metformin on the histology and proliferation of the endometrium in women with endometrial cancer.
2. To assess the effect of body mass index on the response to treatment with metformin
3. To assess the effect of insulin resistance on the response to treatment with metformin
4. To determine effects of metformin on the serum, urine and DNA biomarkers of women with endometrial cancer.

Conditions

Interventions

DRUG

Metformin

850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Pamela Soliman, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-16
Primary Completion
2017-05-28
Completion
2017-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01205672 on ClinicalTrials.gov