An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
OBJECTIVES:
- Compare the frequency of histopathology markers or precursor lesions of the ovaries,
including surface papillomatosis, invaginations, pseudostratification, and inclusion
cysts, removed from patients at increased risk for ovarian cancer between those
receiving fenretinide vs those undergoing immediate oophorectomy.
- Determine the relative abundance of markers of cell proliferation and apoptosis in
cancer-prone ovaries of patients treated with fenretinide.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo prophylactic oophorectomy.
- Arm II: Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8
weeks. Treatment continues in the absence of unacceptable toxicity or diagnosis of
malignancy. After completion of fenretinide, patients undergo prophylactic
oophorectomy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Prevention
Mary B. Daly, MD, PhD
Study Chair
Fox Chase Cancer Center
United States: Food and Drug Administration
CDR0000068655
NCT00017134
September 2002
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Mount Sinai Medical Center | New York, New York 10029 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Colorado Gynecologic Oncology Group P.C. | Aurora, Colorado 80010 |
University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |
Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
George Bray Cancer Center at New Britain General Hospital | New Britain, Connecticut 06050 |