Clinical trial NCT00064025: Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-07-09
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
timeFrame: During the hysterectomy, which is 21-24 days after administration of depo-provera
Secondary outcomes:
measure: Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
timeFrame: During the hysterectomy, which is 21-24 days after administration of depo-provera
measure: Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
timeFrame: During the hysterectomy , which is 21-24 days after administration of depo-provera
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Richard Zaino
role: PRINCIPAL_INVESTIGATOR
References: