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Study Summary
No. 2008-0094:.......Endometrial......Shannon Westin......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		2008-0094
Study Title:A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
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Physician New Patient Referral
Name:Shannon WestinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3358
Contact us about clinical trials
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General Information
Disease Group:EndometrialSupported By:50 CA098258 - 05 - Westin (PI)9/07-8/08
Phase of Study:Phase IIReturn
Visit:		Patients must come to MDACC or the affiliated hospital every three months for a
total of one year.
Treatment
Agents:		Levonorgestrel IUDHome Care:None.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Typically, there will be no hospitalization associated with the pre-treatment
surgery or LIUD treatment.
Description/
Intervention:		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.
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Study Objectives / Outcomes
Primary Objective
1 To determine the efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC), defined as complete regression of disease.
2 To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy.


Secondary Objectives
1 To assess quality of life outcomes in patients treated with Levonorgestrel IUD.
2 To document the toxicity profile of the Levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer.
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Study Status Information
Study Activation / Registration Date:11/03/2008
IRB Review and Approval Date:11/03/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:50
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 (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.
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Links
Registration Number: NCT00788671
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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