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Improving the Treatment for Women With Early Stage Cancer of the Uterus (feMMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686126
Recruitment Status : Active, not recruiting
First Posted : September 17, 2012
Last Update Posted : April 18, 2023
Sponsor:
Collaborators:
The University of Queensland
Queensland University of Technology
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer

Study Description
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Brief Summary:

Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for:

  • young women who still wish to have children and would lose fertility; and
  • women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe.

This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary.

Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).


Condition or disease Intervention/treatment Phase
Complex Endometrial Hyperplasia With Atypia Grade 1 Endometrial Endometrioid Adenocarcinoma Drug: Levonorgestrel Drug: Metformin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium
Actual Study Start Date : December 2012
Actual Primary Completion Date : October 3, 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mirena + Metformin
Metformin tablets, 500mg twice daily orally, 6 months Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
 Drug: Levonorgestrel
Intrauterine device
Other Name: Mirena

Drug: Metformin
oral medication
Experimental: Mirena
Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months
 Drug: Levonorgestrel
Intrauterine device
Other Name: Mirena
Experimental: Mirena + Weight Loss Intervention
Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months Weight Loss Intervention will be delivered via Weight Watchers
 Drug: Levonorgestrel
Intrauterine device
Other Name: Mirena


Outcome Measures
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Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Predict the response to treatment [ Time Frame: 6 months ]
    To predict the response to treatment through blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of "early" EAC.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
  2. Over 18 years of age at time of randomisation
  3. Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
  4. CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
  5. Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
  6. No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
  7. Serum CA125 ≤ 30 U/mL
  8. No hypersensitivity or contraindications for Mirena
  9. Ability to comply with endometrial biopsies at specified intervals
  10. Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
  11. Creatinine < 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)

Exclusion Criteria:

  1. ECOG performance status > 3
  2. Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
  3. Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
  4. Pregnant or planning to become pregnant during trial period
  5. Has had prior treatment or undergoing current treatment for EAC or EHA
  6. Patients with a history of pelvic or abdominal radiotherapy
  7. Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
  8. Unable to provide informed consent
  9. Unable or unwilling to complete questionnaires
  10. Evidence of extrauterine spread on medical imaging
  11. Congenital or acquired uterine anomaly which distorts the uterine cavity
  12. Acute pelvic inflammatory disease
  13. Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
  14. Genital actinomycosis
  15. Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
  16. Breastfeeding mothers
  17. Mirena inserted greater than 12 weeks before randomisation/enrolment
  18. Previous use of Mirena within the last 5 years from randomisation/enrolment
  19. Contraindications to both Metformin and weight loss
Contacts and Locations
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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): NCT01686126


Locations
Show Show 17 study locations
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
The University of Queensland
Queensland University of Technology
Investigators
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Study Chair: Andreas Obermair Queensland Centre for Gynaecological Cancer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT01686126    
Other Study ID Numbers: feMMe
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Queensland Centre for Gynaecological Cancer:
endometrial hyperplasia
endometrial adenocarcinoma
Gynecological Cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Endometrioid
Endometrial Hyperplasia
Hyperplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases
Uterine Diseases
Metformin
Levonorgestrel
Hypoglycemic Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal