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

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ClinicalTrials.gov Identifier: NCT00445887
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : January 11, 2018
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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 cancer from forming. The use of levonorgestrel may prevent ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Other: Laboratory Biomarker Analysis Drug: Levonorgestrel Other: Placebo Phase 2

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. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer
Study Start Date : March 2008
Actual Primary Completion Date : December 2012


Arm Intervention/treatment
Experimental: Arm I (levonorgestrel)
Patients receive oral levonorgestrel once daily.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Levonorgestrel
Given orally
Other Names:
  • 18-Methylnorethisterone
  • D-(-)-Norgestrel
  • L-norgestrel
  • Mirena
  • Norplant
  • Plan B

Placebo Comparator: Arm II (placebo)
Patients receive oral placebo once daily.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Levonorgestrel
Given orally
Other Names:
  • 18-Methylnorethisterone
  • D-(-)-Norgestrel
  • L-norgestrel
  • Mirena
  • Norplant
  • Plan B

Other: Placebo
Given orally
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy




Primary Outcome Measures :
  1. Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue [ Time Frame: Surgical specimen (4 - 6 weeks after entry) ]
    The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide.

  2. Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0 [ Time Frame: Up to 20 weeks ]
    Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death.


Secondary Outcome Measures :
  1. Proportion of Proliferation as Measured by Ki-67 [ Time Frame: Time of surgery (4 to 6 weeks after entry) ]
  2. Patients With High Expression of Transforming Growth Factor-beta 1 [ Time Frame: Baseline to time of surgery (4 to 6 weeks) ]

Other Outcome Measures:
  1. Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue [ Time Frame: Surgical specimen (4-6 weeks after entry) ]
    The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445887


  Hide Study Locations
Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California San Diego
San Diego, California, United States, 92103
United States, Colorado
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States, 80010
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States, 46628
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States, 46391
United States, Kentucky
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States, 27216
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gustavo Rodriguez Gynecologic Oncology Group

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00445887     History of Changes
Other Study ID Numbers: GOG-0214
NCI-2009-00588 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0214
CDR0000532268
GOG-0214 ( Other Identifier: Gynecologic Oncology Group )
GOG-0214 ( Other Identifier: DCP )
GOG-0214 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2007    Key Record Dates
Results First Posted: January 11, 2018
Last Update Posted: January 11, 2018
Last Verified: January 2017
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Levonorgestrel
Norgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral