Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064025

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 II

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:

MedlinePlus related topics: Cancer

Drug Information available for: Medroxyprogesterone 17-acetate Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Histologic response [ Designated as safety issue: No ]
Steroid receptor status as assessed by immunohistochemistry (IHC) [ Designated as safety issue: No ]
Growth and apoptosis as assessed by IHC [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2003
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:	Richard Zaino, MD	Milton S. Hershey Medical Center
Investigator:	Harrison G. Ball, MD	Levine Cancer Center at UMass Medical Center - Memorial Campus

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00064025 History of Changes
Other Study ID Numbers:	CDR0000306440, GOG-0211
Study First Received:	July 8, 2003
Last Updated:	September 16, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
Endometrial Neoplasms
Carcinoma, Endometrioid
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Ovarian Neoplasms
Ovarian Diseases

Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on February 09, 2012