Levonorgestrel-Releasing Intrauterine System in Treating Patients with Complex Atypical Hyperplasia or Grade I Endometrial Cancer
This trial is active, not recruiting.
|Conditions||hyperplasia, endometrial cancer|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||November 2008|
|End date||November 2017|
|Trial size||50 participants|
|Trial identifier||NCT00788671, 2008-0094, 50 CA098258 - 05, NCI-2012-02118|
The goal of this clinical research study is to learn the level of effectiveness of the Mirena intrauterine device (levonorgestrel IUD) in treating hyperplasia of the lining of the uterus and/or early-stage cancer of the lining of the uterus. Researchers want to learn if the levonorgestrel IUD can help to shrink or slow the growth of the disease.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Intrauterine placement during surgery.
Complete Regression of Disease
time frame: Assessed at one year.
Female participants at least 18 years old.
Inclusion Criteria: 1. All patients with a diagnosis of complex atypical hyperplasia or 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: 1) desire for future fertility 2) morbid obesity (body mass index > 40) 3) multiple co-morbidities (American Society of Anesthesiology Classification (ASA) Class 3 or 4) 2. No prior treatment for diagnoses in inclusion criteria 1. 3. Women of any racial or ethnic group. 4. Ability to comply with endometrial biopsies every 3 months. 5. Willing and able to sign informed consent. 6. Age greater than 18 years. Exclusion Criteria: 1. Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1. 2. Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen. 3. Evidence of extrauterine spread of disease on imaging or during surgical evaluation. 4. Congenital or acquired uterine anomaly which distorts the uterine cavity. 5. Acute pelvic inflammatory disease. 6. Acute liver disease or previously diagnosed liver tumor (benign or malignant). 7. Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse. 8. Genital actinomycosis. 9. Current carcinoma of the breast. 10. Current pregnancy. 11. Breastfeeding mothers.
|Official title||A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma|
|Principal investigator||Shannon Westin, MD|
|Description||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. In this study, the levonorgestrel intrauterine device is being tested as a treatment for hyperplasia and/or early-stage cancer of the lining of the uterus. Study Surgery and IUD Placement: If you are found to be eligible to take part in this study, you will have a surgical procedure performed on Day 1 of the study (within 1 week after the screening tests). The procedure is called dilation and curettage, and the purpose is to confirm your diagnosis. First you will have a complete pelvic exam, and then the lining of your uterus will be scraped in the operating room in order to remove a sample of tissue. The tissue sample will be used to find out your exact diagnosis. Women who have previously undergone a dilation and curettage (D&C) before for this diagnosis will not have to undergo a second D&C. The Levonorgestrel IUD will then be placed in the clinic. During this surgery, to lower the risk of pain during the procedure, you will receive general anesthesia. The cervix area may also be numbed with anesthetic. You will be asked to sign a separate consent form for this surgical procedure, and the procedure and its risks will be explained to you in more detail at that time. At the time of surgery, the levonorgestrel IUD will be inserted into your uterus, where it will remain in place. Study Visits: After you have the IUD placed, you will return to the clinic for the following study visits. About one (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, you will be re-assessed for eligibility for our study. If you are still eligible, you will have a chest x-ray and MRI of the abdomen. These scans are being performed to check the status of the disease. If your pathology results show that you have disease outside the uterus, you will be unable to take part in the study. The LIUD can be removed in the operating room when you have surgery for removal of disease outside the uterus. You may also have the LIUD removed in clinic. About one (1) month after surgery, you will have a visit to check the placement of your LIUD. This visit may be in our office or at your local doctor's office, whichever you prefer. Placement of the LIUD will be checked first with a pelvic exam. In addition, you may have an ultrasound of your uterus to confirm the location of your LIUD. If the IUD is not in the correct location, it will be replaced at this visit. At Months 3, 6, 9, and 12 after surgery, the following procedures will be performed: - You will be asked about any side effects that you may be experiencing. - You will have a a complete physical exam, including measurement of your vital signs. - Your medical history will be recorded. - You will have a biopsy of the lining of your uterus. To perform this biopsy, a small plastic tube will be placed into your uterus. The tube will scrape off a tissue sample from the lining of your uterus. Biomarker Testing: The leftover tissue after your study surgery will be tested for biomarkers (chemical "markers" in the tissue that may be related to your response to the study drug, levonorgestrel). This biomarker testing will also be performed on the tissue that is leftover after your uterine lining biopsy at Month 3. Length of Study Participation: The first part of this study lasts 12 months, and the levonorgestrel IUD will remain in your uterus during that time. If the disease gets worse or you experience intolerable side effects at any time, you will be taken off study and the levonorgestrel IUD will be removed. In that case, you would not need to return for the follow-up study visits described below. Instead, you would visit your primary gynecologic oncologist (your regular doctor for the disease), who will discuss with you the different treatment options for the disease. At Month 12 of the study, you will be asked if you want to keep the levonorgestrel IUD in place. If you choose to have the levonorgestrel IUD removed at your Month 12 visit, you will be considered "off study" after the Month 12 visit. If you choose to keep the levonorgestrel IUD after Month 12, you will remain on study for as long as the levonorgestrel IUD is still in place. Instead of visiting the study doctor, you will visit your primary gynecologic oncologist after that. Anytime you have check-ups or biopsies of the lining of your uterus as part of your routine medical care, as long as the levonorgestrel IUD is still in place, the results of the check-ups or biopsies will be shared with the study staff and will be used as part of this research study. You will remain "on study" for as long as the levonorgestrel IUD is still in place. You may ask your primary gynecologic oncologist to remove the IUD at any time. This is an investigational study. The levonorgestrel IUD is commercially available and FDA approved as a form of birth control. Its use for the treatment of cancer and hyperplasia is experimental. At this time and for this purpose, it is only being used in research. Up to 70 patients will take part in this multicenter study. Up to 50 will be enrolled at MD Anderson. Up to 20 will be enrolled at the Harris Health System.|
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