Completed

Everolimus, Letrozole, and Metformin for Advanced Endometrial Carcinoma

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Study Aim

This study aims to evaluate the effectiveness of the combination of Everolimus, Letrozole, and Metformin in providing clinical benefits to patients with advanced endometrial carcinoma.

What is being tested

Daily Metformin for Cancer Treatment

+ Daily Letrozole Tablet

+ Daily Everolimus Treatment

Drug
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2013
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: July 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 7, 2013

Actual date on which the first participant was enrolled.

Study Drug Administration: If you are found to be eligible to take part in this study and you are not already taking metformin, you will take metformin before you begin the regular study cycles (Cycles 1 and beyond). This will be called "Cycle 0." You will take metformin by mouth 1 time a day on Days 1-4 of Cycle 0 and then 2 times a day (about 12 hours apart) every day after that. You will take metformin for 7-10 days in Cycle 0 before Cycle 1 begins. If you are already taking metformin, you will continue your regular dose and start Day 1 of Cycle 1. If you are already taking metformin but your dose is less than 1000mg/day, your dose will be slowly raised up to the study dose over the course of 7-10 days and then you will start Cycle 1. In Cycles 1 and beyond, all participants will take all 3 drugs at a time. You should take metformin with food. Starting in Cycle 1, you will take everolimus 1 time a day by mouth at about the same time every day. You should take it either consistently with food every day or consistently without food every day. Starting in Cycle 1, you will take letrozole 1 time a day by mouth at about the same time every day. It is very important for you to take the study drugs just as the study doctor tells you. Do not skip any doses unless your study doctor tells you to skip doses. If you throw up after taking the study drugs, you should NOT take another tablet that day. Let your study doctor know that you got sick. If you forget to take the study drugs one day, do not take any extra doses the next day. Call your study doctor and ask for advice. There are 4 weeks in each cycle (except Cycle 0). Study Visits: Every cycle (+/- 10 days): * You will have a physical exam, including measurement of your vital signs and weight. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * Blood (about 2 tablespoons) will be drawn for routine tests. * If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for hepatitis. After Cycles 2, 4, and 6 and then every 3 cycles after that (Cycles 9, 12, 15, and so on) (+/- 10 days): * You will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. * If the disease could be felt in the pelvis at the beginning of the study, you will have a pelvic exam After every other cycle (Cycles 2, 4, and so on), blood (about 1 teaspoon) will be drawn for routine tests. Length of Treatment: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End-of-Treatment Visit: Within 4 weeks after the last dose of study drugs: * You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * Blood (about 2 tablespoons) will be drawn for routine tests. * You will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. Follow-Up: You will have follow-up visits as often as the doctor thinks is needed. At every visit: * You will have a physical exam, including measurement of your vital signs. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * If the doctor thinks it is needed, you will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. As often as the doctor thinks is needed, the study staff will call you to ask about side effects you may have had. These calls should last 5-10 minutes. . This is an investigational study. Everolimus is FDA approved and commercially available to treat kidney, breast, and pancreatic cancers. Letrozole is FDA approved and commercially available to treat breast cancer and ovarian cancer. Metformin is FDA approved and commercially available to treat diabetes. The combination of everolimus, metformin, and letrozole in this study to treat endometrial cancer is investigational. Up to 64 patients will be enrolled in this study. Up to 59 may take part at MD Anderson. Up to 5 patients per site may be enrolled at MD Anderson Cooper and Spartanburg Regional Healthcare System and Harris Health System.

NCT01797523
Principal SponsorM.D. Anderson Cancer Center
Last updated: July 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesEndometrial Neoplasms

Criteria

12 inclusion criteria required to participate
Adequate bone marrow function as shown by: ANC >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, Hb > 9 g/dL
Adequate liver function as shown by: a. serum bilirubin <= 1.5 x ULN b. ALT and AST <= 2.5x ULN ( <= 5x ULN in patients with liver metastases); Adequate renal function:serum creatinine < 1.4mg/dL (per manufacturer, metformin is contraindicated in the presence of renal dysfunction defined as a serum creatinine > 1.4 mg/dL in females and in patients with abnormal clearance) ; Fasting serum cholesterol <= 240 mg/dL OR <= 7.75 mmol/L AND fasting triglycerides <= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
Age >= 18 years
All patients must have measurable disease per RECIST 1.1 defined as at least one target lesion that can be accurately measured in at least one dimension ( >= 10mm longest dimension to be recorded; Lymph nodes must be >= 15 mm per short axis). Each lesion must be > 20 mm when measured by palpation or conventional imaging techniques (CT or MRI - based on primary physician preference) or > 10 mm with spiral CT scan. Measurable lesions must be at least 2 times the slice thickness in millimeters. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is confined to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
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18 exclusion criteria prevent from participating
CONTINUED FROM 10 - e. Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; f. A known history of HIV seropositivity; g. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection); h. Patients with an active, bleeding diathesis
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
History of noncompliance to medical regimens
Other malignancies within the past 3 years except for basal or squamous cell carcinomas of the skin
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants start with Metformin alone for 7-10 days. Then, they add Letrozole and Everolimus to their daily routine. Metformin dose increases to twice a day, while Letrozole and Everolimus are taken once daily.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Sacred Heart Health Systems

Pensacola, United StatesOpen Sacred Heart Health Systems in Google Maps

MD Anderson Cooper Cancer Center

Voorhees Township, United States

Memorial City Medical Center

Houston, United States

Lyndon B Johnson General Hospital

Houston, United States
Completed6 Study Centers