Phase II Study of Everolimus and Letrozole, with or without Ribociclib, for Advanced or Recurrent Endometrial Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03008408
This study is testing whether adding the drug ribociclib to everolimus and letrozole can better control endometrial cancer that has spread or returned after treatment. The goal is to see if this combination can stop cancer growth more effectively than everolimus and letrozole alone.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This clinical trial is exploring how well a combination of drugs—everolimus and letrozole, with or without ribociclib—works in treating endometrial cancer that has either spread to other parts of the body or come back after treatment. Ribociclib may help stop cancer cells from growing by blocking certain enzymes. Everolimus and letrozole are known to help stop cancer growth by killing cancer cells, preventing them from dividing, or stopping them from spreading. The study aims to find out if adding ribociclib to everolimus and letrozole is more effective than using everolimus and letrozole alone.
Description
The main goal of this study is to see if adding ribociclib to everolimus and letrozole can help patients with advanced or recurrent endometrial cancer live longer without the disease getting worse. Researchers will also look at how long patients live overall and how well they tolerate the treatment. They will check for any side effects and see if certain genetic mutations affect how well the treatment works. Patients will be randomly assigned to one of two groups: one group will receive ribociclib, everolimus, and letrozole, while the other group will receive only everolimus and letrozole. Treatment cycles will repeat every 28 days as long as the cancer does not progress and side effects are manageable. After finishing the treatment, participants will have follow-up visits at 30 days and then every three months.
Eligibility Criteria
Inclusion Criteria
- Must have signed a consent form and be able to follow the study requirements.
- Must have a confirmed diagnosis of endometrial cancer that has spread or returned and is not curable by standard treatments.
- Must agree to a tumor biopsy before starting treatment, unless a recent biopsy is available.
- Must have had no more than two previous chemotherapy treatments for recurrent cancer.
- Previous radiation therapy is allowed.
- Previous treatment with letrozole is allowed if there has been a 10-day break before starting the study.
- Must have measurable cancer that can be tracked using standard criteria.
- Must not be pregnant or breastfeeding and must agree to use effective birth control if of childbearing potential.
- Must have stopped all other cancer treatments at least four weeks before starting the study.
- Must have a good performance status and meet specific blood and organ function criteria.
Exclusion Criteria
- Cannot have certain types of uterine cancer, such as uterine sarcomas or clear cell carcinomas.
- Cannot be receiving other cancer treatments or have received them within four weeks of starting the study.
- Cannot have unresolved side effects from previous cancer treatments, except for certain mild conditions.
- Cannot have had major surgery within 14 days before starting the study.
- Cannot be participating in other clinical trials or taking investigational drugs.
- Cannot be on long-term steroid treatment or have received live vaccines recently.
- Cannot have active brain cancer unless stable and not requiring treatment.
- Cannot have another active cancer or severe medical condition that could interfere with the study.
- Cannot have a history of heart disease or certain heart conditions.
- Cannot have gastrointestinal issues that affect drug absorption.
- Cannot be taking certain medications that interact with the study drugs.
- Cannot have liver disease or have been treated with mTOR inhibitors before.
- Cannot have allergies to the study drugs or be unable to follow the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lyndon Baines Johnson General Hospital | 77026-1967 | Houston | Texas |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.