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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of Response
Secondary outcome measures
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4
Median Progression-free Survival
Median Survival
Other outcome measures
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
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,852 Total Patients Enrolled
21 Trials studying Endometrial Cancer
4,335 Patients Enrolled for Endometrial Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,276 Total Patients Enrolled
4 Trials studying Endometrial Cancer
186 Patients Enrolled for Endometrial Cancer
GOG FoundationLead Sponsor
41 Previous Clinical Trials
16,067 Total Patients Enrolled
4 Trials studying Endometrial Cancer
1,498 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke in the last 6 months.I have had hormonal therapy for endometrial cancer.My cancer has spread to my brain.I do not have any ongoing or uncontrolled infections.I am not planning to get any live vaccines within a week of starting everolimus or during the study.My endometrial cancer is advanced and cannot be cured by surgery or radiation.I have at least one measurable tumor.I have had chemoradiotherapy for a pelvic recurrence.I have not taken everolimus or drugs targeting the PI3K/AKT/mTOR pathway.I have or had another type of invasive cancer.I have had only one chemotherapy treatment before.I can take medications by mouth.I am fully active and can carry on all my pre-disease activities without restriction.It has been over 4 weeks since my last major surgery or radiation therapy.I've had chemotherapy for early-stage cancer before it spread.I am 18 years old or older.I have a condition that affects how my body absorbs medication.I am allergic to Everolimus or similar medications.My diabetes is not under control.I have a known history of heart disease.I am on long-term steroids or other drugs that weaken my immune system.I am currently experiencing active bleeding or have a condition that puts me at high risk for bleeding.My organs and bone marrow are working well.My lung function is severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Everolimus and Letrozole
- Group 2: Hormonal Therapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different places is this trial taking place?
"In addition to other locations, this research is taking place at Memorial Health University Medical Center in Savannah, Georgia; Sanford Roger Maris Cancer Center in Fargo, North dakota; and The University of Pennsylvania in Philadelphia, Pennsylvania."
Answered by AI
What other scientific papers have been published that mention Letrozole?
"As of right now, 301 different clinical trials are underway that involve the use of letrozole. Out of those 301 trials, 74 are in phase 3. Most research for this medication is conducted in Shanghai but there are over 15000 other locations running similar studies."
Answered by AI
How many people are eligible for this research?
"This particular clinical trial is not presently looking for candidates. The study was first posted on February 1st, 2015 and the most recent update occurred on September 28th, 2021. However, there are other studies that might be of interest; as of now, there are 294 trials actively recruiting patients with advanced endometrial cancer and 301 trials for Letrozole admitting participants."
Answered by AI
What is the typical use case for Letrozole?
"Letrozole is frequently used to manage endometrial hyperplasia. This medication can also assist with other issues like pain, pharmaceutical preparations, and estrogen receptors."
Answered by AI
Could you explain the dangers associated with taking Letrozole?
"There is limited data surrounding Letrozole's efficacy, but it has shown some promise in terms of safety. Therefore, it received a score of 2."
Answered by AI
Are there any available spots for new participants in this research project?
"This particular clinical trial is not actively recruiting patients at the moment, according to data on clinicaltrials.gov. This study was first posted on February 1st, 2015 and updated last on September 28th, 2021. There are 595 other trials that are currently looking for participants."
Answered by AI
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