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

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00788671
• Other study ID #: 2008-0094
• Secondary ID: NCI-2012-0211820
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 3, 2008
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: November 30, 2024
• Est. primary completion date: June 10, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Endometrial Hyperplasia
• 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

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Levonorgestrel-Releasing Intrauterine System
Undergo placement of a levonorgestrel-releasing intrauterine system

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson General Hospital	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson in Katy	Houston	Texas
United States	The Woman's Hospital of Texas	Houston	Texas
United States	MD Anderson League City	Nassau Bay	Texas
United States	MD Anderson in Sugar Land	Sugar Land	Texas
United States	MD Anderson in The Woodlands	The Woodlands	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate at 12 Month	Will be defined as complete response or partial response based on the endometrial biopsy.	At 1 year
Primary	Efficacy of the Levonorgestrel Intrauterine Device (IUD)	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 disease. The primary efficacy endpoint was pathologic response rate (RR) at 12 months defined as complete response (CR) or partial response (PR). CR was defined as no evidence of cancer or hyperplasia with atypia in patients with (CAH) or EEC. PR was defined as CAH in patients with EEC. Progressive disease (PD) was defined as grade 2 endometrioid endometrial cancer or above in patients with EEC or the presence of any cancer in patients with CAH.	At 1 year
Secondary	Quality of Life Score Using the Short Form-36 (SF-36) Survey	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from "0=much worse now" to "4=much better now". Higher subscale and summary score reflect better health status.	At baseline, 3 month, 6 month, 9 month and 12 month

External Links

•   M D Anderson Cancer Center