Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Complete Response Rate - 6 Months
研究概览
简要总结
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.
详细描述
STUDY OBJECTIVES Primary Objective
-To compare the rate of CR at 6 months in non-surgical grade 1 EC and CAH patients receiving metformin + LR-IUD to 50%
Secondary Objectives
- to estimate the rate of CR at 6 months separately in grade 1 EC and CAH patients receiving metformin + LR-IUD
- to estimate the rate of CR at 12 months in non-surgical grade 1 EC and CAH patients receiving metformin + LR-IUD
- to document patient adherence to long-term (≥3 months) metformin administration
- To describe safety of metformin + LR-IUD treatment
Exploratory Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- 未提供
研究组 & 干预措施
Metformin
Metformin, 850 mg. twice daily.
干预措施: Metformin (Drug)
结局指标
主要结局
Complete Response Rate - 6 Months
时间窗: Up to 6 months
Complete Response is subjects with complex atypical hyperplasia or Grade 1 endometrial adenocarcinoma percentage of individuals achieved complete disease regression as defined by no evidence of microscopic viable hyperplasia or carcinoma on endometrial biopsy.
次要结局
- Percent Complete Response Rate-12 Months(Up to 12 months)
- Adherence of Treatment(12 months)
- Treatment Attributed Adverse Events(Up to 12 months)
- Complete Response Rate by Group(Up to 6 months)