Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
PURPOSE: This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer (IND# 79,610)|
- Percent of apoptotic epithelial cells [ Designated as safety issue: No ]
- Frequency and severity of adverse effects by NCI CTC v.3.0 [ Designated as safety issue: Yes ]
- Proliferation [ Designated as safety issue: No ]
- Transforming growth factor-beta expression [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral levonorgestrel once daily.
Placebo Comparator: Arm II
Patients receive oral placebo once daily.
- Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.
- Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients.
- Assess the safety of this drug in these patients.
OUTLINE: This is a prospective, randomized, placebo-controlled, double-blind study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral levonorgestrel once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity, including on the day of surgery. Patients then undergo prophylactic salpingo-oophorectomy*.
After completion of study therapy, patients are followed at 1 year.
NOTE: * Patients who are unable to have surgery completed during the expected 4-6 weeks, may continue levonorgestrel or placebo for a time period no > 5 months. Patients unable to undergo surgery within 5 months are removed from the study.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.