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

March 27, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, United States, 77026-1967
        • Lyndon Baines Johnson General Hospital
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas
      • Houston, Texas, United States, 77094
        • MD Anderson in Katy
      • Nassau Bay, Texas, United States, 77058
        • MD Anderson League City
      • Sugar Land, Texas, United States, 77478
        • MD Anderson in Sugar Land
      • The Woodlands, Texas, United States, 77384
        • MD Anderson in The Woodlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (levonorgestrel-releasing intrauterine system)
Patients undergo placement of a levonorgestrel-releasing intrauterine system.
Other: Laboratory Biomarker Analysis
Correlative studies
Device: Levonorgestrel-Releasing Intrauterine System
Undergo placement of a levonorgestrel-releasing intrauterine system
Other Names:
  • Mirena
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate at 12 Month
Time Frame: At 1 year
Will be defined as complete response or partial response based on the endometrial biopsy.
At 1 year
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
Time Frame: At 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Score Using the Short Form-36 (SF-36) Survey
Time Frame: At baseline, 3 month, 6 month, 9 month and 12 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shannon N Westin, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2008

Primary Completion (Actual)

June 10, 2016

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimated)

November 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0094 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2012-02118 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P50CA098258 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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