Spots Global Cancer Trial Database for Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
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Trial Identification
Brief Title: Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer
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 ID: NCT00445887
Conditions
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California San Diego, San Diego, California, United States
Colorado Gynecologic Oncology Group, Aurora, Colorado, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Northwestern University, Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States
Elkhart Clinic, Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
IU Health La Porte Hospital, La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville, Westville, Indiana, United States
Saint Elizabeth Medical Center South, Edgewood, Kentucky, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Lakeland Hospital Niles, Niles, Michigan, United States
Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cone Health Cancer Center at Alamance Regional, Burlington, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
University of Cincinnati/Barrett Cancer Center, Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
The Don and Sybil Harrington Cancer Center, Amarillo, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Contact Details
Name: Gustavo C Rodriguez
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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