Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00064025
First received: July 8, 2003
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Endometrial Cancer
Drug: medroxyprogesterone
Genetic: microarray analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: October 2003
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DEPO-PROVERA

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

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No history of thrombophlebitis or thromboembolic disorders

Other

  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis
  • No concurrent aminoglutethimide

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No prior cancer treatment that would preclude study therapy
  • No concurrent bosentan
  • No concurrent rifampin
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064025

Locations
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
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Richard Zaino, MD Milton S. Hershey Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00064025     History of Changes
Other Study ID Numbers: GOG-0211, GOG-0211
Study First Received: July 8, 2003
Results First Received: January 31, 2014
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent endometrial carcinoma
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
endometrial adenoacanthoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Endometrioid
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014