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”

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).

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: April 2004

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.

Intervention(s) in this Clinical Trial

• Drug: medroxyprogesterone
• Procedure: conventional surgery
• Procedure: gene expression profiling
• Procedure: neoadjuvant therapy

Primary Measures

• Histologic response
  • Safety Issue?: No
• Steroid receptor status as assessed by immunohistochemistry (IHC)
  • Safety Issue?: No
• Growth and apoptosis as assessed by IHC
  • Safety Issue?: No

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gynecologic Oncology Group

Overall Clinical Trial Officials and Contacts

Richard Zaino, MD Study Chair Milton S. Hershey Medical Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00064025

Study ID Number: CDR0000306440

ClinicalTrials.gov Identifier: NCT00064025

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database