Ovarian Cancer Clinical Trial
Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
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.
Full 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.
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
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There are 35 Locations for this study
Los Angeles California, 90095, United States
Aurora Colorado, 80010, United States
Hartford Connecticut, 06102, United States
New Britain Connecticut, 06050, United States
Fort Lauderdale Florida, 33308, United States
Evanston Illinois, 60201, United States
Indianapolis Indiana, 46260, United States
South Bend Indiana, 46601, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40536, United States
Royal Oak Michigan, 48073, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Park Minnesota, 55416, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
St Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Voorhees New Jersey, 08043, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28232, United States
Akron Ohio, 44307, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43222, United States
Mayfield Heights Ohio, 44124, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Allentown Pennsylvania, 18105, United States
Galveston Texas, 77555, United States
Burlington Vermont, 05401, United States
Richmond Virginia, 23298, United States
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