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.