Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

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

Treatments: Drug: Medroxyprogesterone; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00064025

U10CA027469 (U.S. NIH Grant/Contract)

GOG-0211 (Other Identifier)

NCI-2012-02539 (Registry Identifier)

CDR0000306440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

• Performance status - GOG 0-3

• No history of thrombophlebitis or thromboembolic disorders

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

• No prior therapeutic progesterone or anti-estrogen therapy within 3 months before diagnosis

• No concurrent aminoglutethimide

• No prior cancer treatment that would preclude study therapy

• No concurrent bosentan

• No concurrent rifampin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Treatment (medroxyprogesterone)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Medroxyprogesterone

Procedure: Therapeutic Conventional Surgery