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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)

Phase 2
30 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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)



- 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.

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 NOTE:
*Ovarian cancer in relatives includes invasive ovarian epithelial cancer,
fallopian tube cancer, and primary papillary serous carcinoma of the peritoneum;
no germ cell tumors, granulosa cell tumors, or ovarian tumors of low malignant

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Percent of apoptotic epithelial cells

Safety Issue:


Principal Investigator

Gus Rodriguez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NorthShore University HealthSystem Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms



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