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Active Not Recruiting NCT00788671

Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer

Conditions: 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

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 69
Sponsor: M.D. Anderson Cancer Center

Location: Lyndon Baines Johnson General Hospital Houston Texas

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00788671). StuddyBuddy aggregates publicly available trial information.