Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
RATIONALE: Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.
PURPOSE: 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).
Genetic: microarray analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
- Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ] [ Designated as safety issue: No ]
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.
- Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression [ Time Frame: During the hysterectomy, which is 21-24 days after administration of depo-provera ] [ Designated as safety issue: No ]Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.
- Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression [ Time Frame: During the hysterectomy , which is 21-24 days after administration of depo-provera ] [ Designated as safety issue: No ]Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.
|Study Start Date:||October 2003|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) 400 MG IM, GIVEN ONCE, 21-24 DAYS PRIOR TO HYSTERECTOMY.
STANDARD SURGICAL THERAPY (TAH, BSO, +/- LYMPH NODE SAMPLING) (PARAFFIN BLOCK OF TUMOR MUST BE AVAILABLE OR 16 SECTIONS OF 5 MICRON THICKNESS ON CHARGED SLIDES SUITABLE FOR STANDARD IMMUNOHISTOCHEMISTRY ASSAYS)
|Drug: medroxyprogesterone Genetic: microarray analysis Procedure: conventional surgery Procedure: neoadjuvant therapy|
- 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.
- Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.
- 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.
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.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064025
|United States, Connecticut|
|Helen and Harry Gray Cancer Center at Hartford Hospital|
|Hartford, Connecticut, United States, 06102-5037|
|George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus|
|New Britain, Connecticut, United States, 06050|
|United States, Illinois|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612-7243|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Nevada|
|Women's Cancer Center - Lake Mead|
|Las Vegas, Nevada, United States, 89102|
|United States, Ohio|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45267|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Oregon|
|Williamette Gynecologic Oncology PC|
|Portland, Oregon, United States, 97213|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Richard Zaino, MD||Milton S. Hershey Medical Center|