A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
研究概览
简要总结
This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.
II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
III. Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.
OUTLINE: This is a pilot, multicenter study.
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
- •Histologically confirmed primary endometrioid adenocarcinoma of the uterine corpus
- •All histologic grades and stages eligible
- •Diagnosis by endometrial curettage or biopsy within the past 8 weeks
- •Must have the initial tissue block or 16 unstained sections of 5 micron thickness available
- •Performance status - GOG 0-3
- •No history of thrombophlebitis or thromboembolic disorders
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
- •No concurrent aminoglutethimide
- •No prior cancer treatment that would preclude study therapy
- •No concurrent bosentan
- •No concurrent rifampin
排除标准
- 未提供
研究组 & 干预措施
Treatment (medroxyprogesterone)
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (medroxyprogesterone)
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.
干预措施: Medroxyprogesterone (Drug)
Treatment (medroxyprogesterone)
Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
时间窗: During the hysterectomy, which is 21-24 days after administration of depo-provera
To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data. PR Positivity is based on aggregate score \>0.2 (vs. \<=0.2). Aggregate score based on product of staining intensity and area.
次要结局
- Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression(During the hysterectomy, which is 21-24 days after administration of depo-provera)
- Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression(During the hysterectomy , which is 21-24 days after administration of depo-provera)