What side effects are associated with this type of intervention?

Common treatments for endometrial cancer that are similar to Everolimus and Letrozole include mTOR inhibitors and aromatase inhibitors. mTOR inhibitors like Everolimus can cause side effects such as mouth ulcers, infections, fatigue, and gastrointestinal issues. Aromatase inhibitors like Letrozole may lead to side effects including hot flashes, joint pain, osteoporosis, and cardiovascular issues. Both treatments aim to inhibit cancer cell growth but come with a range of potential adverse effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

Everolimus (Afinitor®) has received FDA approval for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. While not specifically approved for endometrial cancer, everolimus is being studied for its efficacy in this context. Aromatase inhibitors like letrozole and exemestane are also used in hormone receptor-positive cancers, including breast cancer, and are being investigated for their potential in treating endometrial cancer.

What other types of research exist?

Promising novel alternatives for endometrial cancer treatment in 2024 include: 1) Pembrolizumab plus Lenvatinib, an immunotherapy and VEGF receptor inhibitor combination, which has shown significant improvements in progression-free survival. 2) Temsirolimus, another mTOR inhibitor, which has been evaluated in combination with other agents like bevacizumab. 3) Single-agent immunotherapies such as Nivolumab and Pembrolizumab, which have shown efficacy in advanced cases. These alternatives offer different mechanisms of action and have demonstrated potential in recent clinical trials.

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mTOR inhibitor

Everolimus + Letrozole for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by Sinai Hospital of Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have relapse or refractory or persistent epithelial ovarian, fallopian tube, primary peritoneal carcinoma or endometrial cancer. Histologic documentation of the original primary tumor is required via pathology report

Post-menopausal or post-oophorectomy

Must not have

Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus) or to Letrozole

Patients who have any severe and/or uncontrolled medical conditions such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; Symptomatic congestive heart failure of New York heart Association Class III or IV; active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active or chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA), known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air), active, bleeding diathesis; Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, then every 12 weeks while on everolimus and letrozole up to 36 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, Everolimus and Letrozole, to treat women with specific types of recurrent or persistent cancers. Everolimus stops cancer cells from growing, and Letrozole reduces hormones that some cancers need to grow.

Who is the study for?

This trial is for post-menopausal women with recurrent or persistent ovarian, fallopian tube, primary peritoneal, or endometrial cancer that's resistant to platinum-based chemotherapy. Participants must have a performance status of ECOG 2 or better and can't have severe medical conditions like unstable heart disease, serious infections, severely impaired lung function, active bleeding disorders, or liver disease.

What is being tested?

The study tests the effectiveness of combining Everolimus (Afinitor®), an FDA-approved drug for various cancers including advanced kidney and breast cancer among others, with Letrozole in treating women whose ovarian or endometrial cancer has returned despite treatment.

What are the potential side effects?

Everolimus may cause side effects such as mouth ulcers, infections due to immune system suppression, lung problems like coughing and shortness of breath; skin issues; delayed wound healing; and increased cholesterol levels. Letrozole can lead to hot flashes, joint pain/stiffness/arthritis; fatigue; osteoporosis; high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer (ovarian, fallopian tube, peritoneal, or endometrial) has come back or hasn't responded to treatment.

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I am post-menopausal or have had my ovaries removed.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer got worse while I was on my first platinum-based chemotherapy.

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My cancer got worse within a year after my last platinum-based chemotherapy.

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My cancer returned after second round of platinum-based treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to Everolimus, sirolimus, temsirolimus, or Letrozole.

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You have severe heart, liver, lung, or infectious diseases that are not under control, or you are on long-term treatment with corticosteroids or other immune-suppressing medications.

Select...

I haven't had cancer treatment or radiation in the last 4 and 2 weeks, respectively.

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I have a GI condition that affects how my body absorbs pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, then every 12 weeks while on everolimus and letrozole up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, then every 12 weeks while on everolimus and letrozole up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, then every 12 weeks while on everolimus and letrozole up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SingleExperimental Treatment1 Intervention

This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

mTOR inhibitors, such as Everolimus, work by blocking the mTOR pathway, which is crucial for cell growth and proliferation. By inhibiting this pathway, these drugs can slow down or stop the growth of cancer cells. Aromatase inhibitors, like Letrozole, reduce the production of estrogen by blocking the enzyme aromatase, which converts androgens to estrogen. Since some endometrial cancers are estrogen-dependent, lowering estrogen levels can help control the growth of these tumors. These treatments are significant for Endometrial Cancer patients as they target specific pathways involved in cancer progression, potentially leading to more effective and personalized treatment options.