Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
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ClinicalTrials.gov Identifier: NCT00033358 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : May 3, 2013
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Condition or disease | Intervention/treatment | Phase |
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Endometrial Cancer | Drug: medroxyprogesterone Drug: ethinyl estradiol Drug: norgestrel Other: laboratory biomarker analysis | Phase 2 |
PRIMARY OBJECTIVES:
I. The primary objective is to evaluate the effect of progesterone therapy versus combination estrogen and progesterone therapy on potential surrogate endpoint biomarkers (SEBs) relevant to endometrial carcinogenesis.
II. To evaluate changes in histology and ultrasound appearance of the endometrium in women with HNPCC after 3 months of progesterone therapy versus combination estrogen and progesterone therapy compared with baseline.
III. To establish a point estimate of the baseline frequency of endometrial abnormalities looking at histological and molecular markers in a cohort of females carrying an HNPCC gene mutation.
OUTLINE: 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC |
Study Start Date : | February 2002 |
Actual Primary Completion Date : | October 2007 |

Arm | Intervention/treatment |
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Experimental: Arm I (medroxyprogesterone)
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 intramuscularly
Other Names:
Other: laboratory biomarker analysis Correlative studies |
Experimental: Arm II (ethinyl estradiol, norgestrel)
Patients receive 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
Other Names:
Drug: norgestrel Given orally
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Change in potential SEBs relevant to endometrial carcinogenesis. [ Time Frame: From baseline to completion of hormone therapy ]
- Changes in histology and ultrasound appearance of the endometrium in women with HNPCC [ Time Frame: From baseline to 3 months ]

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Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with known mutation of an HNPCC-associated gene (hMLH-1, hMSH-2, or hMSH-6) or fulfill Amsterdam Criteria and have had one or more HNPCC-associated cancers
- No prior hysterectomy; (participants may be scheduled for prophylactic hysterectomy following the study)
- Voluntary consent documented by a signed and witnessed informed consent
- Negative serum pregnancy test at baseline evaluation
- No history of pelvic irradiation for whatever cause
- No chemotherapy for two years
- Women >= 40 must have had a screening mammogram within the last 12 months prior to participation in this study
- Women who are at 50% risk of having a mutation and willing to have genetic testing
Exclusion Criteria:
- Use of oral contraceptives or depoMPA or hormonal exposure, such as hormonal IUD, tamoxifen, raloxifene, or other selective estrogen receptor modulators (SERMs) within four months of initiating study; women will be asked to be off oral contraceptives or other hormonal exposure for 4 months prior to initiating study
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Medical contraindication to use of oral contraceptives or depoMPA including:
- Known or suspected pregnancy
- Undiagnosed vaginal bleeding
- Known or suspected malignancy of breast or endometrium
- Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease
- Gall bladder disease or liver dysfunction or disease, including hepatic adenomas or carcinoma, or abnormal liver function tests
- Known hypersensitivity to depoMPA contraceptive injection (medroxyprogesterone acetate or any of its other ingredients)
- Depression that is currently not under control, in the judgement of the Principal Investigator
- History of epilepsy
- History of diabetes
- Coronary artery disease
- Age >=35 and a current tobacco smoker
- Known inability to participate in the scheduled follow-up tests (i.e., alcohol dependence or illicit drug use)
- Significant medical history or psychiatric problems which would make the participant a poor protocol candidate, in the opinion of the principal investigator
- Post surgical removal of both ovaries
- Postmenopausal women with amenorrhea greater than 12 months
- Previous history of endometrial biopsy, hysteroscopy, dilatation and curettage, or IUD in place within the past 3 months
- Known participation in a concurrent protocol with a pharmacological intervention
- Recent or concurrent use of systemic steroids (i.e. prednisone) within the past four months of initiating study
- Positive serum pregnancy test at baseline evaluation
- Fasting triglycerides level >= 400 mg/dl
- Cholesterol level >= 240 mg/dl
- LDL level >= 160 mg/dl
- HDL level =< 35 mg/dl
- Hypertension that is currently not under good control, in the judgement of the principal investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033358
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Karen Lu | M.D. Anderson Cancer Center |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033358 |
Other Study ID Numbers: |
NCI-2013-00466 ID01-340 CDR0000069277 NCI-P02-0218 MDA-ID-01340 N01CN05127 ( Other Grant/Funding Number: US NIH Grant/Contract Award Number ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | May 3, 2013 |
Last Verified: | April 2013 |
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Medroxyprogesterone Acetate Medroxyprogesterone Norgestrel Estradiol Ethinyl Estradiol |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |