Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer

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Brief Title

Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer

Official Title

Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer

Brief Summary

      The overall goal of this proposal is to investigate the potential benefit of metformin as a
      novel therapy for the treatment of endometrial cancer. Investigators will evaluate the effect
      of short-term metformin treatment on the endometrium of obese women with endometrial cancer
      by comparing each patient's endometrial biopsy before treatment with metformin to their
      post-treatment hysterectomy specimen.

      Participants: Obese women who are to undergo surgical staging for endometrial cancer will
      also receive short-term treatment (1-4 weeks) with metformin that will continue until the day
      prior to surgical staging.

      The effect of metformin on proliferation, apoptosis and downstream signaling pathways will be
      compared between pre-treatment endometrial biopsies and post-treatment hysterectomy
      specimens. Tissue microarrays will be constructed and immunohistochemstry performed to
      evaluate proliferation, apoptosis and changes in critical signaling pathways mediated by
      metformin, and these findings will be correlated with our in vitro preclinical studies. Fresh
      tissue will also be obtained, and Western immunoblotting will be used to assess expression of
      the phosphorylated forms of the downstream targets of metformin. The hypothesis is that
      treatment with metformin will result in a decrease in proliferative markers and an increase
      in markers of apoptosis in the endometrial cancer tumors. AMPK phosphorylation and inhibition
      of critical downstream targets of the mTOR pathway will be seen in the post-treatment
      hysterectomy specimens. Metabolomic profiling will also be performed of tumors and associated
      biofluids (i.e. serum and urine) before and after treatment with metformin to identify
      potential biomarkers of response to this therapy.
    


Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in Ki-67 mean levels between pre-metformin treatment endometrial biopsies and post-metformin treatment hysterectomy specimens


Condition

Endometrial Cancer

Intervention

Metformin

Study Arms / Comparison Groups

 Arm 1
Description:  

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

28

Start Date

May 2011

Completion Date

February 2013

Primary Completion Date

February 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Be between the ages of 18-75 years old

          -  Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on
             pre-operative endometrial biopsy or dilation and curettage (D&C)

          -  Be obese (BMI greater than or equal to 30) with or without diabetes

          -  Have no contraindications to short-term metformin therapy

          -  Have a serum creatinine greater 1.0 mg/dL

          -  Have normal serum transaminase values (AST and ALT)

          -  Need to be able to undergo metformin treatment for a minimum of 1 weeks but no more
             than a maximum of 4 weeks prior to surgical staging

        Exclusion Criteria:

          -  Are currently taking metformin or have taken metformin in the past 6 months or have a
             history of an allergic reaction or intolerance at any time to metformin

          -  Have a history of liver or renal dysfunction

          -  Have a history of alcoholism

          -  Have a history of vitamin B12 deficiency

          -  Are pregnant

          -  Are currently taking insulin

          -  Are currently taking any hormonal therapy or have been on hormonal therapy in the past
             4 weeks

          -  Are taking a drug that may significantly interact or influence the metabolism of
             metformin

          -  In the opinion of the investigator, the patient is felt not to be appropriate for the
             study
      

Gender

Female

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Victoria Bae-Jump, M.D. PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01911247

Organization ID

LCCC1102

Secondary IDs

1K23CA143154-01A1

Responsible Party

Sponsor

Study Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Victoria Bae-Jump, M.D. PhD, Principal Investigator, UNC Lineberger Comprehensive Cancer Center


Verification Date

July 2013