Last updated on September 2017

Phase II Study of Intrauterine Device (IUD) Alone or in Combination With Everolimus in Endometrial Cancer


Brief description of study

You are being asked to take part in this study because you have endometrial hyperplasia (a pre-cancerous growth of the lining of the uterus) and/or early-stage endometrial cancer. The goal of this clinical research study is to learn if the Mirena intrauterine device (levonorgestrel IUD), alone or in combination with everolimus, is effective for the treatment of endometrial hyperplasia and/or early-stage endometrial cancer. This is an investigational study. The levonorgestrel IUD is commercially available and FDA approved as a form of birth control. The use of the IUD itself to treat endometrial cancer is investigational. Everolimus is FDA approved and commercially available to treat kidney, breast, and pancreatic cancers. The combination of everolimus and the levonorgestrel IUD in this study to treat endometrial cancer is investigational. Up to 270 patients will be enrolled in this study. Up to 250 will take part at MD Anderson and up to 20 will take part at the Harris Health System.

Detailed Study Description

Stage 1 Study Visits: The Levonorgestrel IUD: This study will have 2 stages. If you are found to be eligible to take part in this study, in Stage 1, you will receive the levonorgestrel IUD. The levonorgestrel IUD is a T-shaped birth control device that is made of flexible plastic. It is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy. The IUD is placed during an exam of the pelvis. The uterine size is measured and the IUD placed directly into your uterus. This placement may be done at the time of the dilation and curettage (D&C, explained below) or during a routine clinic visit. Removal of the IUD is typically done during a clinic visit during a routine pelvic exam. The IUD strings are located, grasped, and used to remove the device. Study Surgery and IUD Placement: On Day 1 (within 1 week after screening) you will have a standard of care procedure called dilation and curettage (D&C) to confirm the diagnosis. You would have this procedure even if you did not take part in this study. For this procedure, you will have a pelvic exam, and then you will receive general anesthesia to put you to sleep. You may also receive medication to numb the cervix. During this procedure a small amount of tissue will be scraped from the uterus. You will sign a separate consent form describing this procedure and its risks in more detail. During the D&C, the levonorgestrel IUD will be placed in your uterus. If you have recently had a D&C, the procedure will not need to be repeated. Instead, the IUD will be placed during a clinic visit. About 1 week after surgery, the study staff will review your surgery and pathology results with you. If the results showed that you had a change in your diagnosis from hyperplasia to early-stage cancer, the doctor will decide if you are still eligible to take part in this study. If the pathology results show that there is grade 2 or higher cancer in the uterus, you will be unable to take part in the study. The levonorgestrel IUD can be removed in the operating room when you have surgery for removal of disease outside the uterus. You may also have the levonorgestrel IUD removed in the clinic. At 4 weeks after surgery, you will have a physical exam, including a pelvic exam. Placement of the levonorgestrel IUD will be checked during the pelvic exam. This visit may be in our office or at your local doctor's office, whichever you prefer. In addition, you may have an ultrasound of your uterus to confirm the location of your IUD. If the IUD is not in the correct location, it will be replaced at this visit. Stage 1 Study Visits: At 3 months after the IUD placement, you will have an endometrial biopsy (a biopsy of the uterine lining) to check the status of the disease. This is standard care and would be done even if you did not take part in this study. If the biopsy shows that the disease has gotten worse, you will be taken off study and other treatment options will be discussed with you. If the disease appears to have become stable, you will continue on to Stage 2 of the study (described below). You will also have a physical exam and blood (about 2 tablespoons) drawn for routine tests at this visit. If the disease appears to have responded completely, you will have a standard of care biopsy 3 months later to confirm the response. If confirmed, you will then be followed every 6 months with a standard of care biopsy until the disease appears to get worse or you and/or your physician decide to remove the IUD and come off study. If a complete response is not confirmed at the 6-month biopsy visit, you will be taken off study and the doctor will talk with you about options including surgical or non-surgical treatment. Stage 2 Study Groups: If at 3 months after IUD placement the disease has remained stable, you will be assigned to a study group. You will be randomly assigned (as in a roll of dice) to 1 of 2 arms. This is done because no one knows if one arm is better, the same, or worse than the other arm. - If you are in Arm 1, you will continue on the levonorgestrel IUD alone. - If you are in Arm 2, you will receive everolimus every day in addition to continuing on the levonorgestrel IUD. Stage 2 Study Drug Administration: If you are in Arm 2, at 3 months after IUD placement, you will take everolimus 1 time a day by mouth at about the same time every day. You should take it either consistently with food every day or consistently without food every day. Each cycle in Stage 2 is 28 days. On Day 1 of Cycles 1-4, you will use a steroid-based mouth wash to help prevent side effects. You may stop taking this if the doctor thinks it is needed. Stage 2 Study Visits--Arm 1 only: If you are in Arm 1, at 6 Months after IUD placement. - You will have a physical exam, including a pelvic exam. - You will have an endometrial biopsy to check the status of the disease. If the disease appears to get better or stay the same. You will then be followed every 3 months with a standard of care biopsy until the disease appears to get worse or you and/or your physician decide to remove the IUD and come off study. You will have a physical exam and biopsy at 9 months and 1 year. If your disease appears to have gotten worse at the 9-month or 1-year biopsy, or your disease has stayed the same at the time of the 1-year biopsy, you will come off study and the doctor will talk with you about options including surgical or non-surgical treatment. If you have a complete response at the time of the 1-year biopsy, you will have a standard of care biopsy 3 months later to confirm the response. If confirmed, you will then have a standard of care biopsy every 6 months until the disease appears to get worse or you and/or your physician decide to remove the IUD. Stage 2 Study Visits--Arm 2 only: If you are in Arm 2, on Day 1 of each Cycle: - You will have a physical exam, including a pelvic exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for hepatitis or to check your liver function. If you are in Arm 2, at Cycles 3, 6 and 9: - You will have a physical exam, including a pelvic exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have a follow-up endometrial biopsy to check the status of the disease. - If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check your liver function. If you are in Arm 2, on Cycle 1 and every 3rd cycle (Cycles 1, 4, 7, and so on) until the end of treatment. °Blood (about 1 tablespoon) will be drawn to check your blood levels of fat If the disease appears to have completely responded at the time of the Cycle 9 biopsy, you will have an endometrial biopsy to confirm the response at Cycle 12. If confirmed, you will have a biopsy every 6 cycles as long you are on study. You will also have the following tests and procedures 1 time each cycle starting at Cycle 10: - You will have a physical exam, including a pelvic exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check your liver function. If the disease appears to have gotten worse at the time of the Cycle 3, 6, or 9 biopsy, you will stop taking everolimus and come off study. The doctor will talk with you about surgical and/or non-surgical treatment options. If the disease has remained stable at the time of the Cycle 9 biopsy, you will come off study and the doctor will talk with you about surgical and/or non-surgical treatment options. Biomarker Testing: Leftover tissue from a previous procedure will be tested for biomarkers. Biomarkers are found in the blood/tissue and may be related to your response to levonorgestrel. Biomarker testing will also be performed on leftover tissue from the Month 3 EMB, Month 6 EMB and Cycle 3 (only if you are in Arm 2), and if you have a hysterectomy. End-of-Treatment Visit (Arm 2 only): After you are no longer receiving the study treatment(s): - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests.

Clinical Study Identifier: NCT02397083

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Shannon Westin, MD

Memorial City
Houston, TX United States
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Shannon Westin, MD

Lyndon B. Johnson General Hospital (LBJ)
Houston, TX United States
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Shannon Westin, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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Shannon Westin, MD

The Woman's Hospital of Texas
Houston, TX United States
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