Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00017134
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether fenretinide given before surgery is more effective in preventing ovarian cancer than surgery alone.
PURPOSE: Randomized clinical trial to compare the effectiveness of fenretinide followed by surgery with that of surgery alone in preventing ovarian cancer in patients who are at increased risk.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
George Bray Cancer Center at New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Evanston Northwestern Healthcare - Evanston Hospital
🇺🇸Evanston, Illinois, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Colorado Gynecologic Oncology Group P.C.
🇺🇸Aurora, Colorado, United States
Oregon Health & Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States