Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
NCT ID: NCT00445887
Last Updated: 2019-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2008-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (levonorgestrel)
Patients receive oral levonorgestrel once daily.
Laboratory Biomarker Analysis
Correlative studies
Levonorgestrel
Given orally
Arm II (placebo)
Patients receive oral placebo once daily.
Laboratory Biomarker Analysis
Correlative studies
Levonorgestrel
Given orally
Placebo
Given orally
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Levonorgestrel
Given orally
Placebo
Given orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
30 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Gustavo C Rodriguez
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Diego
San Diego, California, United States
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00588
Identifier Type: REGISTRY
Identifier Source: secondary_id
10-01367
Identifier Type: -
Identifier Source: secondary_id
CDR0000532268
Identifier Type: -
Identifier Source: secondary_id
GOG-0214
Identifier Type: -
Identifier Source: secondary_id
GOG-0214
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0214
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0214
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0214
Identifier Type: -
Identifier Source: org_study_id
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