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)
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Percent of apoptotic epithelial cells
No
Gus Rodriguez, MD
Study Chair
NorthShore University HealthSystem Research Institute
United States: Food and Drug Administration
GOG-0214
NCT00445887
March 2008
Name | Location |
---|---|
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 |