Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
Ovarian Cancer
About this trial
This is an interventional prevention trial for Ovarian Cancer focused on measuring ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- Colorado Gynecologic Oncology Group P.C.
- Helen and Harry Gray Cancer Center at Hartford Hospital
- George Bray Cancer Center at New Britain General Hospital
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Evanston Northwestern Healthcare - Evanston Hospital
- St. Vincent Indianapolis Hospital
- Memorial Hospital of South Bend
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- William Beaumont Hospital - Royal Oak Campus
- University of Minnesota Medical Center & Children's Hospital - Fairview
- CCOP - Metro-Minnesota
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Siteman Cancer Center at Barnes-Jewish Hospital
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey at Cooper - Voorhees
- Roswell Park Cancer Institute
- Mount Sinai Medical Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- McDowell Cancer Center at Akron General Medical Center
- Charles M. Barrett Cancer Center at University Hospital
- Riverside Methodist Hospital Cancer Care
- Mount Carmel Health - West Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Oklahoma University Medical Center
- Oregon Health & Science University Cancer Institute
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- University of Texas Medical Branch
- Fletcher Allen Health Care - University Health Center Campus
- Virginia Commonwealth University Massey Cancer Center