Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Condition: Atypical Endometrial Hyperplasia; Stage I Uterine Corpus Cancer AJCC v7; Stage IA Uterine Corpus Cancer AJCC v7; Stage IB Uterine Corpus Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Intervention: Laboratory Biomarker Analysis; Levonorgestrel-Releasing Intrauterine System; Quality-of-Life Assessment
Intervention description: Correlative studies; Undergo placement of a levonorgestrel-releasing intrauterine system; Ancillary studies
Intervention MeSH terms: Levonorgestrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well levonorgestrel-releasing intrauterine system works in
      treating patients with complex atypical hyperplasia or grade I endometrial cancer. High
      levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help
      balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of
      progesterone, may fight endometrial cancer by helping regulate hormone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

          -  No prior treatment for diagnoses in inclusion criteria 1.

          -  Women of any racial or ethnic group.

          -  Ability to comply with endometrial biopsies every 3 months.

          -  Willing and able to sign informed consent.

          -  Age greater than 18 years.

        Exclusion Criteria:

          -  Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of
             the 3 criteria mentioned in inclusion criteria 1.

          -  Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial
             biopsy or on dilation and curettage specimen.

          -  Evidence of extrauterine spread of disease on imaging or during surgical evaluation.

          -  Congenital or acquired uterine anomaly which distorts the uterine cavity.

          -  Acute pelvic inflammatory disease.

          -  Acute liver disease or previously diagnosed liver tumor (benign or malignant).

          -  Conditions associated with increased susceptibility to infections with microorganisms.
             Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.

          -  Genital actinomycosis.

          -  Current carcinoma of the breast.

          -  Current pregnancy.

          -  Breastfeeding mothers.