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Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer Clinical research trials and Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer. Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer  Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
For Condition: Endometrial Cancer,hereditary non-polyposis colon cancer (hMSH2, hMLH1, hPMS1, hPMS2)
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Hormone therapy may prevent the development of endometrialcarcinogenesis (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: Randomizedphase 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.
Details: OBJECTIVES: - Compare the effect of medroxyprogesterone vs ethinyl estradiol and norgestrel on potential surrogate endpoint biomarkers relevant to endometrial carcinogenesis in women with a known hereditary non-polyposis colon cancer (HNPCC)-associated gene mutation or HNPCC-associated cancer(s). - Compare the 3-month changes in histology and ultrasound appearance of the endometrium in patients treated with these preventive regimens. 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. - 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 and oral placebo once daily on days 22-28. 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. PROJECTED ACCRUAL: A total of 68 patients (34 per arm) will be accrued for this study within 22.7-34 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 25 Years/50 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Meets criteria for 1 of the following: - Known hereditary non-polyposis colon cancer (HNPCC)-associated mutation of MLH1, MSH2, MSH3, MSH6, PMS1, or PMS2 identified by gene sequencing - Fulfills Amsterdam criteria with 1 or more HNPCC-associated cancers - No known or suspected malignancy of the breast or endometrium - Must have had a screening mammogram within the past 12 months if age 40 or over PATIENT CHARACTERISTICS: Age: - 25 to 50 Sex: - Female Menopausal status: - No postmenopausal patients with amenorrhea for more than 1 year Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No liver dysfunction or disease (e.g., hepatic adenomas or carcinoma) - Liver function tests normal Renal: - Not specified Cardiovascular: - No active thrombophlebitis - No prior or concurrent thromboembolic disorders or cerebrovascular disease - No concurrent hypertension that is not well controlled - No coronary artery disease Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective barrier contraception during the first month of study therapy - No undiagnosed vaginal bleeding - No gallbladder disease - No hypersensitivity to medroxyprogesterone contraceptive injection - No concurrent uncontrolled depression - No prior or concurrent epilepsy - No prior or concurrent diabetes - No tobacco smoking for patients age 35 to 50 - No alcohol dependence or illicit drug use - No other significant medical history or psychiatric problems that would preclude study participation - Fasting triglycerides no greater than 400 mg/dL - Cholesterol no greater than 240 mg/dL - Low-density lipoprotein (LDL) no greater than 160 mg/dL - High-density lipoprotein (HDL) at least 35 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 2 years since prior chemotherapy Endocrine therapy: - At least 4 months since prior oral contraceptives, medroxyprogesterone, or other hormonal exposure (e.g., hormonal intrauterine device, tamoxifen, raloxifene, or other selective estrogen receptor modulators) - At least 4 months since prior systemic steroids (e.g., prednisone) - No concurrent systemic steroids (e.g., prednisone) Radiotherapy: - No prior pelvic irradiation Surgery: - At least 3 months since prior endometrial biopsy, hysteroscopy, dilation and curettage, or placement of an intrauterine device - No prior hysterectomy (patients may be scheduled for a prophylactic hysterectomy) - No prior bilateral oophorectomy Other: - No other concurrent participation in a protocol with pharmacological intervention
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarenLu, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Karen Lu 713-745-8902
Additional Information:
Study ID Numbers: CDR0000069277; MDA-ID-01340,NCI-P02-0218
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033358
Other Endometrial Cancer Studies:
1. Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
2. Genetic Study of Young Patients With Colorectal Cancer
Related Studies:
Other Endometrial Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
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