Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
NCT ID: NCT00017134
Last Updated: 2013-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
71 participants
INTERVENTIONAL
2002-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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fenretinide
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Increased risk for ovarian cancer secondary to 1 of the following:
* Evidence of a BRCA1 or BRCA2 genetic mutation
* Family history of 1 or more first-degree relatives diagnosed with ovarian cancer prior to 50 years of age
* Family history of 1 first-degree relative with ovarian cancer (any age) AND 1 or more first- or second-degree relatives diagnosed with breast or ovarian cancer
* Personal history of breast cancer (at any age) AND 1 or more first- or second-degree relative diagnosed with breast or ovarian cancer at any age
* Meets any 1 of the following criteria:
* Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast\* and/or ovarian cancer
* Ashkenazi Jewish ethnicity with diagnosed breast\* cancer in patient
* Greater than 20% probability of carrying BRCA1/2 mutation with a family history of breast and ovarian cancer NOTE: \* Where breast cancer is required to meet this criteria, diagnosis must occur prior to menopause or at ≤ 50 years old if age at menopause is unknown
* Planned prophylactic oophorectomy
* Normal pelvic exam within the past 6 weeks
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* GOG 0-1
Life expectancy:
* At least 12 months
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
* Triglyceride less than 2 times ULN (fasting)
Cardiovascular:
* No myocardial infarction within the past 3 months
* No active angina
* No unstable heart rhythms
* No clinically evident congestive heart failure
Other:
* No uncontrolled medical illness that would preclude study participation
* No uncontrolled diabetes
* No uncontrolled psychiatric illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 months since prior chemotherapy
Endocrine therapy:
* At least 3 months since prior hormonal therapy
* At least 8 weeks since prior hormone replacement therapy
* At least 8 weeks since prior oral, injectable, or implantable contraceptives
* No concurrent hormonal therapy, including hormone replacement therapy
Radiotherapy:
* At least 3 months since prior radiotherapy
* No prior radiotherapy to pelvis for malignancy
Surgery:
* See Disease Characteristics
Other:
* At least 3 months since prior investigational treatment
* No concurrent nutritional supplements except a daily multivitamin with less than 25,000 IU of vitamin A
* No prior non-steroidal anti-inflammatory drugs (NSAIDs) on a regular (chronic or daily) basis within the past 6 months
* No concurrent NSAIDs on a regular (chronic or daily) basis
* Concurrent aspirin at a dose of 81 mg/day allowed
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Mary B. Daly, MD, PhD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Colorado Gynecologic Oncology Group P.C.
Aurora, Colorado, 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
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 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
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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GOG-0190
Identifier Type: -
Identifier Source: secondary_id
CDR0000068655
Identifier Type: -
Identifier Source: org_study_id
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