- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033358
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given intramuscularly
Other Names:
|
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.
|
Correlative studies
Given orally
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in potential SEBs relevant to endometrial carcinogenesis.
Time Frame: From baseline to completion of hormone therapy
|
From baseline to completion of hormone therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in histology and ultrasound appearance of the endometrium in women with HNPCC
Time Frame: From baseline to 3 months
|
From baseline to 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Lu, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Estradiol
- Ethinyl Estradiol
- Medroxyprogesterone Acetate
- Medroxyprogesterone
- Norgestrel
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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