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

NCT00445887 | Completed Phase 2 Results

• 5 other identifiers: GOG-0214NCI-2009-0058810-01367CDR0000532268U10CA101165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 66

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.

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Surgical specimen (4 - 6 weeks after entry)

• 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.

  Up to 20 weeks

Secondary Outcomes (2)

• Proportion of Proliferation as Measured by Ki-67

  Time of surgery (4 to 6 weeks after entry)

• Patients With High Expression of Transforming Growth Factor-beta 1

  Baseline to time of surgery (4 to 6 weeks)

Other Outcomes (1)

• Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue

  Surgical specimen (4-6 weeks after entry)

Study Arms (2)

Arm I (levonorgestrel)

EXPERIMENTAL

Patients receive oral levonorgestrel once daily.

Other: Laboratory Biomarker Analysis; Drug: Levonorgestrel

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo once daily.

Other: Laboratory Biomarker Analysis; Drug: Levonorgestrel; Other: Placebo

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (levonorgestrel); Arm II (placebo)

Levonorgestrel DRUG

Given orally

Also known as: 18-Methylnorethisterone, D-(-)-Norgestrel, L-norgestrel, Mirena, Norplant, Plan B

Arm I (levonorgestrel); Arm II (placebo)

Placebo OTHER

Given orally

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (66)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Colorado Gynecologic Oncology Group

Aurora, Colorado, 80010, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, 60521, United States

Location

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Hinsdale, Illinois, 60521, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46514-2098, United States

Location

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, 46514, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

IU Health La Porte Hospital

La Porte, Indiana, 46350, United States

Location

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, 46545, United States

Location

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, 46545, United States

Location

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, 46563, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, 46601, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States

Location

Michiana Hematology Oncology PC-Westville

Westville, Indiana, 46391, United States

Location

Saint Elizabeth Medical Center South

Edgewood, Kentucky, 41017, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Lakeland Hospital Niles

Niles, Michigan, 49120, United States

Location

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, 49085, United States

Location

Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati/Barrett Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Linda Gedeon for James Kauderer, MA
• Organization: NRG Oncology

lgedeon@gogstats.org

716-845-1169

Study Officials

• Gustavo C Rodriguez

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: March 10, 2008
• Primary Completion: December 11, 2013
• Last Updated: November 19, 2019
• Results First Posted: January 11, 2018

Record last verified: 2019-11

Locations

US (66)