Everolimus + Letrozole for Endometrial Cancer

Palo Alto (17 mi)

Pamela T. Soliman | MD Anderson Cancer ...

Overseen byPamela T. Soliman

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.

Eligibility Criteria

This trial is for adults with advanced or recurrent endometrial cancer that has progressed. Participants must have tried fewer than two chemotherapy regimens, not be pregnant, and have no severe concurrent diseases. They should not have used certain cancer treatments recently and must not be of childbearing potential.

Inclusion Criteria

My liver is working well.

My cholesterol and triglyceride levels are within normal limits.

My kidneys work well, with a function over 50cc/min.

I am 18 years old or older.

I can take care of myself and am up and about more than 50% of my waking hours.

My endometrial cancer has come back or is getting worse.

Exclusion Criteria

I have previously taken RAD001, mTOR inhibitors, letrozole, or aromatase inhibitors.

I have uterine sarcoma or a mixed malignant mullerian tumor.

My cancer recurrence can potentially be cured with surgery or radiation.

I do not have severe liver, kidney, or digestive diseases.

My ovaries are functioning normally.

I have a known history of heart disease.

I have a history of severe lung problems.

I have untreated brain metastases.

I have cancer cells in the fluid around my brain and spinal cord.

I am allergic to everolimus or similar medications.

I am not currently on chemotherapy or radiotherapy and haven't been for the last 4 weeks.

I am on long-term steroids or other drugs that affect my immune system.

I am currently taking antibiotics for an active infection.

Treatment Details

The study tests the effectiveness and safety of combining RAD001 (Everolimus) with Letrozole in controlling recurrent or progressive endometrial cancer. It aims to find out if this drug combination can help patients whose disease has returned or worsened after treatment.

1Treatment groups

Experimental Treatment

Group I: Letrozole + RAD001Experimental Treatment2 Interventions

Letrozole and RAD001 (Everolimus)

Letrozole is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Femara for:

Breast cancer in postmenopausal women
Increasing the chance of ovulation in women with polycystic ovary syndrome

🇪🇺 Approved in European Union as Letrozole for:

Early breast cancer in postmenopausal women
Advanced breast cancer in postmenopausal women

🇨🇦 Approved in Canada as Letrozole for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer