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Status:

COMPLETED

Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Ovarian Carcinoma

Eligibility:

FEMALE

30+ years

Phase:

PHASE2

Brief 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 c...

Detailed Description

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. ...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    March 10 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00445887

    Start Date

    March 10 2008

    Last Update

    November 19 2019

    Active Locations (66)

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    Page 1 of 17 (66 locations)

    1

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010

    2

    USC / Norris Comprehensive Cancer Center

    Los Angeles, California, United States, 90033

    3

    UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, United States, 92868

    4

    University of California San Diego

    San Diego, California, United States, 92103