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

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ClinicalTrials.gov Identifier: NCT00788671
Recruitment Status : Active, not recruiting
First Posted : November 11, 2008
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Device: Levonorgestrel-Releasing Intrauterine System Other: Quality-of-Life Assessment Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma
Actual Study Start Date : November 3, 2008
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


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 Name: Mirena

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Response to therapy [ Time Frame: At 1 year ]
    Will be defined as complete response or partial response. Will estimate the treatment success rate with 90% credible interval.


Secondary Outcome Measures :
  1. Change in expression levels as measured by immunohistochemistry (IHC) [ Time Frame: Baseline to up to 3 months ]
    Will be tested with a paired t-test. Because genetic profile information is highly skewed, natural log transformations will be made to the data prior to calculating change from baseline and completing the t-test. Change in immunohistochemical expression will be analyzed for association with response using a chi-square analysis. Proteins relevant to proliferation and estrogen-signaling will be assessed by IHC.

  2. Change in expression levels as measured by reverse transcriptase-polymerase chain reaction (RT-PCR) [ Time Frame: Baseline to up to 3 months ]
    Genes relevant to proliferation, estrogen-signaling and Wnt signaling will be assessed by RT-PCR.

  3. Incidence of Toxicity [ Time Frame: Up to 1 year ]
    We will calculate the percentage of subjects who have period prevalence and incidence of recurrence along with a 95% confidence intervals. Incidence is calculated as the number of patients who recur divided by person-time follow-up. Summary statistics will be completed on LIUD toxicity.

  4. Incidence of complications [ Time Frame: Up to 1 year ]
    Summary statistics will also be completed on LIUD complications.

  5. Quality of life score using the Short Form-36 (SF-36) survey [ Time Frame: Up to 1 year ]
    The SF-36 is a patient self-reported survey that measures health status across 8 subscales and is scored using weighted sums of the questions in the different subscales. Each subscale score is transformed to a 0 to 100 scale. Higher scores reflect better functioning, while lower scores reflect poorer functioning: physical functioning- ability to perform physical activities; role-physical - ability to work or perform daily activities due of physical health; bodily pain- higher scores reflect less pain and fewer limitations due to pain; general health- reflect better evaluation of personal health; vitality- reflect more "pep" and energy; social functioning- reflect better ability to perform normal social activities without interference due to physical or emotional problems; role-emotional- reflect better ability to work or perform daily activities due to emotional problems; mental health- reflect better feelings of peacefulness, happiness and calm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (American Society of Anesthesiology [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

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, acquired immune deficiency syndrome (AIDS), leukemia and intravenous (IV) drug abuse
  • Genital actinomycosis
  • Current carcinoma of the breast
  • Current pregnancy
  • Breastfeeding mothers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788671


Locations
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United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026-1967
M D Anderson Cancer Center
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
MD Anderson in Katy
Houston, Texas, United States, 77094
MD Anderson League City
Nassau Bay, Texas, United States, 77058
MD Anderson in Sugar Land
Sugar Land, Texas, United States, 77478
MD Anderson in The Woodlands
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Shannon N Westin M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00788671     History of Changes
Other Study ID Numbers: 2008-0094
NCI-2012-02118 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0094 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
P50CA098258 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levonorgestrel
Uterine Neoplasms
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral