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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Histologic response

Safety Issue:

No

Principal Investigator

Richard Zaino, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000306440

NCT ID:

NCT00064025

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Endometrial Neoplasms
  • Carcinoma, Endometrioid
  • Adenoma

Name

Location

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Williamette Gynecologic Oncology PCPortland, Oregon  97213