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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Medroxyprogesterone; Medroxyprogesterone Acetate; Norgestrel; Polyestradiol phosphate

Criteria

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