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Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

2014-08-27 03:56:13 | BioPortfolio

Summary

RATIONALE: Hormone therapy may prevent the development of endometrial carcinogenesis (cancer) in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.

PURPOSE: Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer.

Description

OBJECTIVES:

- Compare the effect of medroxyprogesterone vs ethinyl estradiol and norgestrel on potential surrogate endpoint biomarkers relevant to endometrial carcinogenesis in women with a known hereditary non-polyposis colon cancer (HNPCC)-associated gene mutation or HNPCC-associated cancer(s).

- Compare the 3-month changes in histology and ultrasound appearance of the endometrium in patients treated with these preventive regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.

All patients undergo a baseline transvaginal ultrasound and endometrial biopsy.

- Arm I: Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

- Arm II: Patients receive oral contraceptive pills (OCP) comprising ethinyl estradiol and norgestrel once daily on days 1-21. Treatment repeats every 28 days for 3-4 courses (3-4 packs of OCP) in the absence of unacceptable toxicity. Approximately 1 week after starting the fourth pack of OCP, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.

Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in continued endometrial screening.

PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Prevention

Conditions

Endometrial Cancer

Intervention

ethinyl estradiol, medroxyprogesterone, norgestrel

Location

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
California
United States
94115

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:13-0400

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Medical and Biotech [MESH] Definitions

ETHINYL ESTRADIOL and NORGESTREL given in fixed proportions. It has proved to be an effective contraceptive (CONTRACEPTIVES, ORAL, COMBINED).

A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.

A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.

The 3-methyl ether of ETHINYL ESTRADIOL. It must be demethylated to be biologically active. It is used as the estrogen component of many combination ORAL CONTRACEPTIVES.

Neoplasms of the endometrial stroma that sometimes involve the MYOMETRIUM. These tumors contain cells that may closely or remotely resemble the normal stromal cells. Endometrial stromal neoplasms are divided into three categories: (1) benign stromal nodules; (2) low-grade stromal sarcoma, or endolymphatic stromal myosis; and (3) malignant endometrial stromal sarcoma (SARCOMA, ENDOMETRIAL STROMAL).

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