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)
- Determine the impact of levonorgestrel on the relative frequency of apoptosis in the
ovarian epithelium of patients at high risk for ovarian cancer.
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Percent of apoptotic epithelial cells
Gus Rodriguez, MD
NorthShore University HealthSystem Research Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|University of Texas Medical Branch||Galveston, Texas 77555-1329|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Carilion Gynecologic Oncology Associates||Roanoke, Virginia 24014|
|Central Baptist Hospital||Lexington, Kentucky 40503|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|St. Elizabeth Medical Center||Edgewood, Kentucky 41017|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Elkhart General Hospital||Elkhart, Indiana 46515|
|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|Michiana Hematology-Oncology, PC - Elkhart||Elkhart, Indiana 46514|
|Elkhart Clinic, LLC||Elkhart, Indiana 46514-2098|
|Michiana Hematology Oncology PC - La Porte||La Porte, Indiana 46350|
|Michiana Hematology-Oncology, PC - South Bend||Mishawaka, Indiana 46545-1470|
|Michiana Hematology Oncology PC - Plymouth||Plymouth, Indiana 46563|
|Lakeside Cancer Specialists, PLLC||Saint Joseph, Michigan 49085|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center||Pinehurst, North Carolina 28374|
|Gynecologic Oncology||Hinsdale, Illinois 60521|
|Women's Cancer Center - La Canada||Las Vegas, Nevada 89169|
|Good Samaritan Hospital Cancer Treatment Center||Cincinnati, Ohio 45220|