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Ovarian CarcinomaPhase 2NCT00445887

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

A Phase 2 study testing Laboratory Biomarker Analysis and Levonorgestrel in people with Ovarian Carcinoma, run by Gynecologic Oncology Group at 66 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older, women only
Conditions the study is for
Ovarian Carcinoma
What is being tested?
Laboratory Biomarker Analysis and Levonorgestrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
66 sitesUnited States
Study dates
10 Mar 2008to 11 Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Lakeland Hospital Niles

    Niles, Michigan, 49120

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of California San Diego

    San Diego, California, 92103

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Levonorgestrel, Placebo
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • LevonorgestrelDrug

    Also called 18-Methylnorethisterone, D-(-)-Norgestrel, L-norgestrel, Mirena

    Given orally

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given orally

Study groups in NCT00445887
Study groupRoleWhat they receive
Arm I (levonorgestrel)ExperimentalPatients receive oral levonorgestrel once daily.
Receives: Other: Laboratory Biomarker Analysis; Drug: Levonorgestrel
Arm II (placebo)Placebo comparatorPatients receive oral placebo once daily.
Receives: Other: Laboratory Biomarker Analysis; Drug: Levonorgestrel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue

    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.

    Measured: Surgical specimen (4 - 6 weeks after entry)

  2. Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0

    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.

    Measured: Up to 20 weeks

Secondary outcomes (2)

  1. Proportion of Proliferation as Measured by Ki-67

    Measured: Time of surgery (4 to 6 weeks after entry)

  2. Patients With High Expression of Transforming Growth Factor-beta 1

    Measured: Baseline to time of surgery (4 to 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2007 (estimated)
  2. Study start10 Mar 2008
  3. Primary completion11 Dec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445887
Sponsor's protocol ID
GOG-0214
Other IDs
NCI-2009-00588, 10-01367, CDR0000532268, GOG-0214, GOG-0214, GOG-0214, GOG-0214, U10CA101165
Status last verified
Nov 2019
First submitted
7 Mar 2007
Last updated
19 Nov 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Levonorgestrel in people with Ovarian Carcinoma, run by Gynecologic Oncology Group at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue (time frame: Surgical specimen (4 - 6 weeks after entry)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00445887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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