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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033358 |
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.
Condition | Intervention | Phase |
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Endometrial Cancer Hereditary Non-Polyposis Colon Cancer (hmsh2, hmlh1, hpms1, hpms2) |
Drug: ethinyl estradiol Drug: medroxyprogesterone Drug: norgestrel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Active Control |
Official Title: | Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC |
Estimated Enrollment: | 44 |
Study Start Date: | February 2002 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive medroxyprogesterone intramuscularly once on day 1. Approximately 90 days after the injection, patients undergo a repeat transvaginal ultrasound and endometrial biopsy.
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Drug: medroxyprogesterone
Given by injection
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Arm II: Experimental
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.
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Drug: ethinyl estradiol
Given orally
Drug: norgestrel
Given orally
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OBJECTIVES:
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.
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.
Ages Eligible for Study: | 25 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets criteria for 1 of the following:
No known or suspected malignancy of the breast or endometrium
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Nebraska | |
Creighton University Medical Center | |
Omaha, Nebraska, United States, 68131-2197 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Karen H. Lu, MD | M.D. Anderson Cancer Center |
Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Karen H. Lu ) |
Study ID Numbers: | CDR0000069277, MDA-ID-01340, NCI-P02-0218 |
Study First Received: | April 9, 2002 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00033358 |
Health Authority: | United States: Federal Government |
endometrial cancer hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2) |
Medroxyprogesterone 17-Acetate Gastrointestinal Diseases Colonic Diseases Estradiol valerate Urogenital Neoplasms Hereditary nonpolyposis colon cancer Estradiol 17 beta-cypionate Genital Diseases, Female Endometrial Neoplasms Estradiol 3-benzoate Uterine Neoplasms Endometrial cancer Polyestradiol phosphate Digestive System Neoplasms Metabolic Diseases |
Genital Neoplasms, Female Ethinyl Estradiol Uterine Diseases Intestinal Diseases Estradiol Intestinal Neoplasms Norgestrel Neoplastic Syndromes, Hereditary Digestive System Diseases Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Gastrointestinal Neoplasms Medroxyprogesterone Metabolic disorder Colonic Neoplasms |
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents DNA Repair-Deficiency Disorders Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female |
Reproductive Control Agents Contraceptive Agents, Male Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Contraceptives, Oral, Synthetic |