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

Information source: Gynecologic Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer

Intervention: levonorgestrel (Drug); placebo (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Gynecologic Oncology Group

Official(s) and/or principal investigator(s):
Gus Rodriguez, MD, Study Chair, Affiliation: NorthShore University HealthSystem Research Institute


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.

Clinical Details

Official title: Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer (IND# 79,610)

Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Percent of apoptotic epithelial cells

Frequency and severity of adverse effects by NCI CTC v.3.0

Secondary outcome:


Transforming growth factor-beta expression


Detailed description: 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.


Minimum age: 30 Years. Maximum age: N/A. Gender(s): Female.



- 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)

Locations and Contacts

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

Evanston Hospital, Evanston, Illinois 60201-1781, United States

Gynecologic Oncology, Hinsdale, Illinois 60521, United States

Elkhart Clinic, LLC, Elkhart, Indiana 46514-2098, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana 46514, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana 46545-1470, United States

Saint Joseph Regional Medical Center, Mishawaka, Indiana 46545-1470, United States

Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana 46563, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Michiana Hematology Oncology PC - La Porte, Westville, Indiana 46391, United States

St. Elizabeth Medical Center, Edgewood, Kentucky 41017, United States

Central Baptist Hospital, Lexington, Kentucky 40503-9985, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan 49085, United States

Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan 49085, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States

Women's Cancer Center - La Canada, Las Vegas, Nevada 89169, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina 28374, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267, United States

Good Samaritan Hospital Cancer Treatment Center, Cincinnati, Ohio 45220, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

University of Texas Medical Branch, Galveston, Texas 77555-0361, United States

University of Virginia Cancer Center, Charlottesville, Virginia 22908, United States

Carilion Gynecologic Oncology Associates, Roanoke, Virginia 24016, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2008
Last updated: September 19, 2013

Page last updated: August 23, 2015

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