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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionClosed30 and overNCI, OtherGOG-0214
NCI-2009-00588, NCT00445887

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

  • Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer.

Secondary

  • 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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 potential
  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Gus RodriguezStudy Chair

Trial Sites

U.S.A.
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
New York
  New York
 New York University Medical Center
 Stephanie V. Blank Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
North Carolina
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 Janak K. Choksi Ph: 336-538-7725
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Robert Victor Higgins Ph: 704-355-2884

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00445887
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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