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

Tracking Information

First Received Date ^ICMJE

July 8, 2003

Last Updated Date

February 14, 2009

Start Date ^ICMJE

October 2003

Estimated Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Histologic response
Steroid receptor status as assessed by immunohistochemistry (IHC)
Growth and apoptosis as assessed by IHC

Change History

Complete list of historical versions of study NCT00064025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Official Title ^ICMJE

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

Brief Summary

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).

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Endometrial Cancer

Intervention ^ICMJE

Drug: medroxyprogesterone
Genetic: microarray analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

April 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00064025

Responsible Party

Study ID Numbers ^ICMJE

CDR0000306440, GOG-0211

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP