NCT01943058

Brief Summary

This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

2.6 years

First QC Date

September 11, 2013

Last Update Submit

September 9, 2014

Conditions

Atypical Endometrial HyperplasiaEndometrial AdenocarcinomaRecurrent Endometrial CarcinomaStage IA Endometrial CarcinomaStage IB Endometrial CarcinomaStage II Endometrial CarcinomaStage IIIA Endometrial CarcinomaStage IIIB Endometrial CarcinomaStage IIIC Endometrial CarcinomaStage IVA Endometrial CarcinomaStage IVB Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Histologic regression from endometrioid adenocarcinoma or complex atypical hyperplasia to benign endometrium

    Histologic regression will be dichotomized as a binary outcome variable, yes if patients have a confirmed histologic regression at the time of the scheduled biopsy, and no if the histologic regression is not observed regardless of compliance, lost-to-follow-up, or other issues. A contingency table and a bar plot will be used to show the histologic regression rate between the 2 arms. Two-group test of equivalence in proportions will be used to detect whether the histologic regression rate in Arm B is not significantly lower than that in Arm A.

    Up to 6 months after completion of study treatment

Secondary Outcomes (3)

  • Change in weight

    Baseline to up to 6 months after completion of study treatment

  • Change in mood ascertained using the self-reported Beck Depression Inventory-Primary Care (BDI-PC)

    Baseline to up to 6 months after completion of study treatment

  • Compliance

    Up to 6 months after completion of study treatment

Other Outcomes (2)

  • Change in levels of ER stress

    Baseline up to 6 months after completion of study treatment

  • Changes in levels of tumorigenic biomarkers

    Baseline up to 6 months after completion of study treatment

Study Arms (2)

Arm A (megestrol acetate)

EXPERIMENTAL

Patients receive megestrol acetate PO BID for up to 18 months in the absence of disease progression or unacceptable toxicity.

Drug: megestrol acetateOther: laboratory biomarker analysisOther: questionnaire administration

Arm B (levonorgestrel-releasing IUS)

EXPERIMENTAL

Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity.

Device: levonorgestrel-releasing intrauterine systemOther: laboratory biomarker analysisOther: questionnaire administration

Interventions

megestrol acetateDRUG

Given PO

Also known as: BDH 1298, Maygace, Megace, Megestil, Niagestin
Arm A (megestrol acetate)
levonorgestrel-releasing intrauterine systemDEVICE

Given IUD

Also known as: Mirena
Arm B (levonorgestrel-releasing IUS)
laboratory biomarker analysisOTHER

Correlative studies

Arm A (megestrol acetate)Arm B (levonorgestrel-releasing IUS)
questionnaire administrationOTHER

Ancillary studies

Arm A (megestrol acetate)Arm B (levonorgestrel-releasing IUS)

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A histologic diagnosis of complex atypical hyperplasia or grade 1 endometrioid adenocarcinoma of the endometrium diagnoses within 3 months of study enrollment who strongly desire to maintain fertility
  • A diagnosis of endometrioid adenocarcinoma will undergo a magnetic resonance imaging (MRI) scan of the pelvis to rule out deep (\> 50%) myometrial invasion and extrauterine metastases
  • A negative urine or serum pregnancy test at the time of enrollment
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Willing and able to consent for treatment with office endometrial biopsies every 3 months
  • Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

  • A diagnosis of grade 1 endometrioid adenocarcinoma of the endometrium who does not wish to maintain fertility
  • MRI evidence of deep myometrial and/or extrauterine spread
  • Congenital or other structural uterine or tubal abnormality
  • An acute pelvic inflammatory disease or medical conditions, such as, but not limited to acquired immunodeficiency syndrome (AIDS) and chronic immunosuppression, that may be associated with an increased susceptibility to infections
  • Current diagnosis of breast cancer or any other cancer
  • Currently pregnant or breastfeeding
  • Thromboembolic disease, deep vein thrombosis, hypercoagulable state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial HyperplasiaEndometrial Neoplasms

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yvonne Lin-Liu

    University of Southern California

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

March 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

September 10, 2014

Record last verified: 2014-09