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.

Condition	Treatment or Intervention
ovarian epithelial cancer	Drug: fenretinide  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: conventional surgery  Procedure: surgery

Further Study Details: 

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 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.
• Arm II: 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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
• 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

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 6 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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Illinois
      Hinsdale,  Illinois,  60521,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905-0001,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting

Study chairs or principal investigators

Mary B. Daly, MD, PhD,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000068655; GOG-0190; NCT00017134
Record last reviewed:  February 2005
Last Updated:  February 15, 2005
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017134
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08