Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
Condition: Ovarian Carcinoma
MeSH terms: Ovarian Neoplasms
Intervention: Laboratory Biomarker Analysis; Levonorgestrel; Placebo
Intervention description: Correlative studies; Given orally; Given orally
Intervention MeSH terms: Levonorgestrel; Norgestrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Female
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At increased genetic risk for ovarian cancer AND planning to undergo risk-reducing
             salpingo-oophorectomy (RRSO)

               -  Has ≥ 1 intact ovary

          -  Patients enrolled on clinical trial GOG-0199 and planning to undergo RRSO allowed

          -  Submission of fixed ovarian tissue (FN01) required

          -  Must meet 1 of the following additional criteria:

               -  Family of the patient has a documented deleterious BRCA1 or BRCA2 mutation and
                  either the patient herself has tested positive for a deleterious BRCA1 or BRCA2
                  mutation or the patient has a first- or second-degree relative with a deleterious
                  BRCA1 or BRCA2 mutation

                    -  No patient with a deleterious BRCA1 or BRCA2 mutation whose first- or
                       second-degree relative has tested negative for the exact same mutation

               -  The family contains members with ≥ 2 ovarian* and/or breast cancers among the
                  first- or second-degree relatives (male relatives must be counted) of the patient
                  within the same lineage (this condition may be satisfied by multiple primary
                  cancers in the same person or, where breast cancer is required to meet this
                  criterion, ≥ 1 breast cancer must have been diagnosed prior to menopause or at
                  age ≤ 50 years if age at menopause is unknown)

               -  The patient is of Ashkenazi Jewish ethnicity (lineage via the mother) with one
                  first- degree or two second-degree maternal relatives with breast and/or ovarian
                  cancer* (where breast cancer is required to meet this criterion, ≥ 1 breast
                  cancer must have been diagnosed prior to menopause or at age ≤ 50 years if age at
                  menopause is unknown)

               -  The probability of carrying a BRCA1 or BRCA2 mutation, given the family pedigree
                  of breast and ovarian cancers, exceeds 20%, as calculated by BRCAPRO

          -  No prior history of ovarian cancer, including low malignant potential cancers, or
             primary papillary serous carcinoma of the peritoneum

          -  No prior or concurrent history of breast cancer, including ductal carcinoma in situ
             (DCIS) of the breast

               -  Women with a history of hormone receptor-negative breast cancer (both estrogen
                  receptor-negative and progesterone receptor-negative) are eligible

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception prior to the
             prophylactic salpingo-oophorectomy

          -  No prior history of deep vein thrombosis, stroke, liver disease, or heart attack

          -  No prior history of myocardial infarction

          -  No known bleeding disorders or hypercoagulable states

          -  No other malignancy, including ductal carcinoma in situ, within 1 year of systemic
             therapy, except for nonmelanoma skin cancer

          -  No prior chemotherapy regimen lasting ≥ 12 months

          -  No oral or intrauterine hormonal contraception or hormonal replacement therapy within
             the past 3 months or injectable medroxyprogesterone within the past 12 months

          -  No intraperitoneal surgery within the past 3 months (including laparoscopy)

          -  No prior or concurrent radiotherapy to the pelvis

          -  No concurrent hormonal contraception

          -  No concurrent tamoxifen, raloxifene, estrogen, progesterone-like hormones, or other
             hormonal medication (including hormone replacement therapy)