This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
PRIMARY OBJECTIVES: I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer. SECONDARY OBJECTIVES: I. Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients. II. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue
The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.
Time frame: Surgical specimen (4 - 6 weeks after entry)
Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.
Time frame: Up to 20 weeks
Proportion of Proliferation as Measured by Ki-67
Time frame: Time of surgery (4 to 6 weeks after entry)
Patients With High Expression of Transforming Growth Factor-beta 1
Time frame: Baseline to time of surgery (4 to 6 weeks)
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