Phase II Study of Everolimus, Letrozole, and Metformin for Advanced or Recurrent Endometrial Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01797523

Provider View

This study is testing a combination of three drugs—everolimus, letrozole, and metformin—to see if they can help control advanced or returning endometrial cancer. The safety of this drug combination will also be evaluated.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of three drugs—everolimus, letrozole, and metformin—can help manage endometrial cancer that has come back or is not responding to treatment. Everolimus works by blocking a protein that helps cancer grow. Letrozole stops a protein from making estrogen, which may slow cancer growth. Metformin, usually used for diabetes, lowers insulin levels, which might help stop cancer cells from growing.

Description

Study Drug Administration:

  • If you are eligible and not already taking metformin, you will start with metformin alone for about a week (Cycle 0) before beginning the full treatment. You'll take metformin once a day for the first 4 days, then twice a day.
  • If you're already on metformin, you'll continue your dose and start the full treatment (Cycle 1) with all three drugs.
  • In Cycle 1 and beyond, you'll take all three drugs daily: metformin with food, everolimus, and letrozole at the same time each day.
  • It's important to follow the dosing instructions carefully. If you vomit after taking the drugs, do not retake them that day. If you miss a dose, do not double up the next day. Contact your doctor for guidance.

Study Visits:

  • Every cycle (about every 4 weeks), you'll have a physical exam, discuss any side effects, and have blood tests.
  • After certain cycles, you'll have scans to check the cancer's status.

Length of Treatment:

  • You can continue the treatment as long as it's beneficial and you can tolerate it. Treatment will stop if the cancer worsens or side effects become too severe.

End-of-Treatment Visit:

  • Within 4 weeks after stopping the drugs, you'll have a final exam, blood tests, and scans.

Follow-Up:

  • You'll have follow-up visits as needed, including exams and possibly scans.
  • Study staff may call you to check on side effects.

This study is investigational for endometrial cancer, though the drugs are approved for other uses. Up to 64 patients will participate, with most at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or recurrent endometrial cancer that hasn't responded to other treatments.
  • Have had no more than two prior chemotherapy treatments for this cancer.
  • Have measurable disease that can be tracked by scans.
  • Not be of child-bearing potential (surgically sterile or postmenopausal).
  • Be off other cancer treatments for at least four weeks.
  • Be 18 years or older.
  • Have a performance status of 2 or less, meaning you can carry out light work.
  • Have adequate blood, liver, and kidney function as shown by specific tests.
  • Sign an informed consent form.
  • Prior treatment with letrozole is allowed.

Exclusion Criteria

  • Have certain types of uterine cancer like sarcomas or serous histology.
  • Be currently receiving or have recently received other cancer treatments.
  • Have had major surgery recently or need major surgery soon.
  • Be on chronic steroids or immunosuppressive drugs.
  • Have uncontrolled brain metastases or other serious medical conditions.
  • Be pregnant or breastfeeding, or not using effective birth control.
  • Have had prior treatment with mTOR inhibitors.
  • Have a known allergy to the study drugs.
  • Be unable to comply with the study protocol.

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