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



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:30 - Any
Updated:1/13/2018
Start Date:March 2008

Use our guide to learn which trials are right for you!

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.

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.

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)
We found this trial at
54
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
574-389-0414
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Hinsdale, IL
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
La Porte, Indiana 46350
?
mi
from
La Porte, IN
Click here to add this to my saved trials
3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky 40503
?
mi
from
Lexington, KY
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
(574) 237-1328
Michiana Hematology Oncology PC-Mishawaka Michiana Hematology Oncology's Advanced Centers for Cancer Care include the largest...
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
4 Longmeadow Village Dr
Niles, Michigan 49120
(269) 683-4153
Michiana Hematology Oncology PC - Niles In 1968, medical oncologist Thomas Troeger, MD had a...
?
mi
from
Niles, MI
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
1915 Lake Ave
Plymouth, Indiana 46563
574-936-2585
Michiana Hematology Oncology In 1968, medical oncologist Thomas Troeger, MD had a dream to advance...
?
mi
from
Plymouth, IN
Click here to add this to my saved trials
Roanoke, Virginia 24016
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Saint Joseph, Michigan 49085
?
mi
from
Saint Joseph, MI
Click here to add this to my saved trials
3900 Hollywood Road
Saint Joseph, Michigan 49085
(269) 428-4411
Marie Yeager Cancer Center The Marie Yeager Cancer Center is located at the Lakeland Health...
?
mi
from
Saint Joseph, MI
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Savannah, Georgia 31404
?
mi
from
Savannah, GA
Click here to add this to my saved trials
615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
?
mi
from
South Bend, IN
Click here to add this to my saved trials
3975 William Richardson Dr
South Bend, Indiana 46601
(574) 204-7709
Michiana Hematology Oncology In 1968, medical oncologist Thomas Troeger, MD had a dream to advance...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Springfield, Missouri 65804
?
mi
from
Springfield, MO
Click here to add this to my saved trials
1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
Mercy Hospital Springfield We're continuing a tradition of healing more than 120 years old. Mercy...
?
mi
from
Springfield, MO
Click here to add this to my saved trials
1668 South US 421
Westville, Indiana 46391
 219-785-3400
Michiana Hematology Oncology-PC Westville Michiana Hematology Oncology's Advanced Centers for Cancer Care include the largest...
?
mi
from
Westville, IN
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials