Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC
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
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
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
Patients are followed at 6 weeks and are encouraged to return in 6 months to participate in
continued endometrial screening.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Change in potential SEBs relevant to endometrial carcinogenesis.
From baseline to completion of hormone therapy
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|