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.
Additional locations may be listed on ClinicalTrials.gov for NCT00788671.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC).
II. 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:
I. To assess quality of life outcomes in patients treated with levonorgestrel IUD.
II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer.
III. To evaluate the molecular profile of the hysterectomy specimen of patients treated with the levonorgestrel IUD. Compare molecular profile in pretreatment tissue to hysterectomy tissue between responders and non-responders to levonorgestrel IUD therapy.
IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD.
OUTLINE:
Patients undergo placement of a levonorgestrel-releasing intrauterine system.
After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorShannon Neville Westin
