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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Cancer

Intervention: Levonorgestrel Intrauterine Device (LIUD) (Device); Everolimus (Drug); Questionnaire (Behavioral)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Shannon Westin, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Shannon Westin, MD, Phone: 713-794-4314

Summary

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.

Clinical Details

Official title: Phase II Study of the Levonorgestrel Intrauterine Device Alone or in Combination With the mTORC1 Inhibitor, Everolimus, for the Treatment of Complex Atypical Hyperplasia and Stage Ia Grade 1 Endometrial Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response Rate

Secondary outcome: Overall Survival

Detailed 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.

- 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. 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. ( I have added pelvic exam to

all physical exams as this will be standard for these patients at every physical 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 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. 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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. All patients with a diagnosis of complex atypical hyperplasia on endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: morbid obesity (body mass index > 40) or multiple co-morbidities (ASA Class 3 or 4) 2. Prior progesterone treatment for either diagnosis is ALLOWED. 3. Ability to comply with endometrial biopsies every 3 months 4. Age >/= 18 years 5. ECOG performance status /= 1. 5 x 10^9/L; Platelets >/=100 x 10^9/L; Hb >9 g/dL; 7. Adequate liver function as shown by: a) Total serum bilirubin 8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary; 10. Patients who have any severe and/or uncontrolled medical conditions such as: a. unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction /= 3 years 15. Active (acute or chronic) or uncontrolled severe infections, including acute pelvic inflammatory disease 16. Congenital or acquired uterine anomaly which distorts the uterine cavity 17. Genital actinomycosis 18. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study 19. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing. 20. Women who are pregnant or nursing (lactating) women 21. Women of child-bearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must use one additional highly effective methods of contraception in addition to the LIUD during the study and 8 weeks after. Acceptable effective contraception methods include combo of the following: a. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; b. Total abstinence or; c. Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e. g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation > six weeks prior to randomization.

Locations and Contacts

Shannon Westin, MD, Phone: 713-794-4314

Lyndon B. Johnson General Hospital (LBJ), Houston, Texas 77026, United States; Not yet recruiting

Memorial City, Houston, Texas 77024, United States; Not yet recruiting

The Woman's Hospital of Texas, Houston, Texas 77054, United States; Not yet recruiting

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Not yet recruiting

Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: August 2015
Last updated: July 6, 2015

Page last updated: August 23, 2015

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