Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

Completed · Phase 2

Conditions studied: Endometrial Cancer

In brief

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. Hormone therapy may prevent the development of endometrial 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.

Key facts

Study ID

NCT00033358

Run by

National Cancer Institute (NCI)

People needed

52

Starts

2002-02-01

Last updated by the study team

2013-05-03

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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