NCT00064025

Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

Detailed description

PRIMARY OBJECTIVES: I. 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. II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug. III. 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.

Conditions

• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Carcinoma
• Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
• Recurrent Uterine Corpus Carcinoma
• Stage I Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Medroxyprogesterone	Given IM
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgical hysterectomy

Timeline

• Start date: 2004-04-01
• Primary completion: 2010-09-01
• First posted: 2003-07-09
• Last updated: 2016-04-11
• Results posted: 2014-08-15

Locations

1 site across 1 country: United States