Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients

Completed · Phase 2

Conditions studied: Complex Atypical Hyperplasia, Endometrial Cancer

In brief

Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15). Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status.

Key facts

Study ID

NCT02035787

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

20

Starts

2014-02-27

Expected to finish

2024-04-12

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the inclusion criteria to participate in this study:
• Histologically confirmed CAH or grade 1 EC
• Females age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 4
• Non-surgical candidates due to:
• Desire for fertility preserving treatment
• Unacceptable surgical risk as defined by:
• American Society of Anesthesiologists Physical Status (ASA) ≥ 4 and/or Perioperative Cardiac Risk > 5%(45) and/or Perioperative Respiratory Failure Risk > 5%(46)
• AND
• oIndependent medicine or cardiology pre-op consultation concluding 'high' surgical risk.
• Planned treatment with the LR-IUD for CAH or grade 1 EC by primary physician
• Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days of D1 of treatment
• Understand study design, risks, and benefits and have signed informed consent
• Exclusion Criteria Any patient meeting any of the exclusion criteria at baseline will be excluded from study participation.
• Evidence of renal dysfunction (Cr > 1.5mg/dL or Cr clearance < 60 mL/m2) or liver dysfunction (AST/alanine aminotransferase (ALT) > 2x upper limit of normal (ULN))
• Currently receiving progestin therapy (local, topical, or systemic)
• Myometrial invasion >50% or evidence of nodal or metastatic disease on baseline MRI (MRI only to be done for EC patients) or tumor size > 2cm on MRI or pelvic ultrasound
• Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements
• Prior or current use of metformin within the past 3 months
• History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects
• Chronic (daily use for > 1 month) use of cimetidine (significant increase in metformin concentration and risk of lactic acidosis)
• Iodinated contrast agents used in prior 48 hours (significant increase in metformin concentration and risk of lactic acidosis)
• Pregnant or lactating
• Recent (< 4 weeks) active, documented, cervical infection

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• TriHealth — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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