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mTOR Inhibitor

Everolimus + Letrozole or Hormonal Therapy for Endometrial Cancer

Phase 2

Waitlist Available

Research Sponsored by Gynecologic Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must have histologically confirmed advanced (FIGO Stage III or IV), persistent, or recurrent endometrial carcinoma, not likely to be curable by surgery or radiotherapy

Patients must have at least one 'target lesion' to assess response on this protocol as defined by RECIST 1.1

Must not have

Patients who have previously received hormonal therapy for endometrial cancer

Patients with active or uncontrolled systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed throughout the treatment period and for 30 days after discontinuation of treatment. treatment continues until progression of disease.

Awards & highlights

Summary

This trial is studying how well two drugs, everolimus and letrozole, work compared to tamoxifen and medroxyprogesterone acetate in treating endometrial cancer.

Who is the study for?

This trial is for adults with advanced, persistent, or recurrent endometrial cancer who have measurable disease and can take oral medications. They should be in good physical condition with proper organ and marrow function. Only one prior chemotherapy regimen is allowed, and they must not be pregnant or breastfeeding.

What is being tested?

The study compares the effectiveness of Everolimus plus Letrozole against Tamoxifen plus Medroxyprogesterone acetate in treating endometrial cancer. It also assesses the side effects of these drug combinations.

What are the potential side effects?

Potential side effects include reactions to Everolimus such as lung problems, risk of infections due to immune system suppression, blood sugar issues (diabetes), bleeding risks, and hormonal therapy-related effects like hot flashes or mood changes.

Eligibility Criteria

Inclusion Criteria

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

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My endometrial cancer is advanced and cannot be cured by surgery or radiation.

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I have at least one measurable tumor.

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I have had only one chemotherapy treatment before.

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I can take medications by mouth.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had hormonal therapy for endometrial cancer.

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I do not have any ongoing or uncontrolled infections.

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I have not had a stroke in the last 6 months.

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My cancer has spread to my brain.

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I have not taken everolimus or drugs targeting the PI3K/AKT/mTOR pathway.

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I have or had another type of invasive cancer.

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I have a condition that affects how my body absorbs medication.

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I am allergic to Everolimus or similar medications.

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My diabetes is not under control.

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I have a known history of heart disease.

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

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I am currently experiencing active bleeding or have a condition that puts me at high risk for bleeding.

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My lung function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed throughout the treatment period and for 30 days after discontinuation of treatment. treatment continues until progression of disease.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed throughout the treatment period and for 30 days after discontinuation of treatment. treatment continues until progression of disease.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed throughout the treatment period and for 30 days after discontinuation of treatment. treatment continues until progression of disease. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency of Response

Secondary study objectives

Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4

Median Progression-free Survival

Median Survival

Other study objectives

Hormone Receptor Immunohistochemistry

Mutation Analysis

mTOR Pathway Immunohistochemistry

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Everolimus and LetrozoleExperimental Treatment2 Interventions

Everolimus 10 mg daily and Letrozole 2.5 mg PO daily

Group II: Hormonal TherapyActive Control2 Interventions

Tamoxifen 20 mg PO BID; on alternating weeks (even numbered) weeks, Medroxyprogesterone Acetate 200 mg PO daily with Tamoxifen 20 mg PO BID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Letrozole

FDA approved

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor

250 Previous Clinical Trials

65,107 Total Patients Enrolled

21 Trials studying Endometrial Cancer

4,335 Patients Enrolled for Endometrial Cancer

Novartis PharmaceuticalsIndustry Sponsor

2,889 Previous Clinical Trials

4,201,930 Total Patients Enrolled

4 Trials studying Endometrial Cancer

186 Patients Enrolled for Endometrial Cancer

GOG FoundationLead Sponsor

46 Previous Clinical Trials

17,880 Total Patients Enrolled

7 Trials studying Endometrial Cancer

2,401 Patients Enrolled for Endometrial Cancer

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02228681 — Phase 2

Endometrial Cancer Research Study Groups: Everolimus and Letrozole, Hormonal Therapy

Endometrial Cancer Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT02228681 — Phase 2

Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02228681 — Phase 2

~7 spots leftby Sep 2025

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