Trial Summary
What is the purpose of this trial?The goal of this clinical research study is to learn if the combination of everolimus, letrozole, and metformin can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.
Everolimus is designed to block a protein inside cancer cells that is involved in cancer growth.
Letrozole is designed to block a protein from making estrogen. This may interfere with the growth of cancer cells.
Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of endometrial cancer cells.
Eligibility Criteria
This trial is for adults with advanced or recurrent endometrial carcinoma that's resistant to standard treatments. Participants can have had no more than two prior chemo regimens, must not be pregnant or of child-bearing potential, and should have adequate organ function. They cannot join if they've had other cancers (except certain skin cancers) in the past 3 years, known hypersensitivity to everolimus, uncontrolled brain metastases, severe liver impairment, active infections, or are on immunosuppressants.Inclusion Criteria
My blood tests show normal white blood cells, platelets, and hemoglobin levels.
My endometrial cancer is advanced, has returned, and doesn't respond to standard treatments.
I am 18 years old or older.
I haven't taken any cancer treatments, including immunotherapy or hormone therapy, for the last 4 weeks.
Exclusion Criteria
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: a. Symptomatic congestive heart failure of New York heart Association Class III or IV; b. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; c. Severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air; d. Active (acute or chronic) or uncontrolled severe infections
I am allergic to everolimus or similar medications.
My cancer has returned in a specific area and can be treated with surgery or radiation.
I am not pregnant or breastfeeding and use effective birth control.
I haven't had any cancer except skin cancer in the last 3 years.
I do not have uncontrolled brain cancer or need steroids for brain cancer.
I have been treated with an mTOR inhibitor before.
I haven't had any cancer treatments in the last 4 weeks.
My cancer is a specific type of uterine cancer.
Treatment Details
The study tests a combination of three drugs: Everolimus (blocks cancer growth proteins), Letrozole (interferes with estrogen production affecting cancer cell growth), and Metformin (commonly used for diabetes but may slow cancer by lowering insulin levels). The aim is to see if this combo controls endometrial cancer better and understand its safety profile.
1Treatment groups
Experimental Treatment
Group I: Letrozole + Metformin + RAD001Experimental Treatment3 Interventions
Patients have a 7-10 day lead in period where they take Metformin alone. The starting dose of Metformin 500 mg by mouth daily for 4 days and then increased to 500 mg by mouth twice a day. Everolimus and Letrozole added and considered the start of Cycle #1.
Everolimus administered by mouth as once daily dose of 10 mg. Letrozole 2.5 mg tablet by mouth once daily. The oral dose of Everolimus should be taken together with the daily dose of Letrozole 2.5mg.
Everolimus is already approved in United States, European Union, United States for the following indications:
🇺🇸 Approved in United States as Afinitor for:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
🇪🇺 Approved in European Union as Votubia for:
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
🇺🇸 Approved in United States as Zortress for:
- Prevention of organ rejection in kidney transplant patients
Find a clinic near you
Research locations nearbySelect from list below to view details:
Lyndon B Johnson General HospitalHouston, TX
The Woman's Hospital of TexasHouston, TX
MD Anderson Cooper Cancer CenterVoorhees, NJ
University of Texas MD Anderson Cancer CenterHouston, TX
More Trial Locations
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
NovartisIndustry Sponsor