Fenretinide in Preventing Ovarian Cancer in Participants Who Are at High Risk for Developing Ovarian Cancer and Planning to Undergo Surgery to Remove the Ovaries

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer.

PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fenretinide

Criteria

DISEASE CHARACTERISTICS:

• At high risk for developing ovarian cancer, meeting 1 of the following criteria:

• Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer before 50 years of age

• Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer at any age AND ≥ 1 first- or second-degree relative diagnosed with breast or ovarian cancer at any age

• Positive BRCA1/BRCA2 test

• Planning to undergo prophylactic bilateral oophorectomy

PATIENT CHARACTERISTICS:

Age

• 30 and over

Performance status

• Zubrod 0-1

Life expectancy

• At least 12 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 1.5 times ULN

• Alkaline phosphatase ≤ 1.5 times ULN

• No history of liver disease*

• No cholestatic jaundice

• No hepatic adenomas NOTE: *For patients undergoing contrast enhanced ultrasound

Renal

• BUN normal

• Creatinine normal

Cardiovascular

• No history of a congenital heart defect creating a bi-directional or right-to-left shunt*

• No history of congestive heart failure*

• No thrombophlebitis

• No thromboembolic disease

• No cerebral vascular disease

• No coronary artery disease NOTE: *For patients undergoing contrast enhanced ultrasound

Pulmonary

• No history of pulmonary hypertension*

• No history of pulmonary emboli*

• No history of severe emphysema* NOTE: *For patients undergoing contrast enhanced ultrasound

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• Thyroid stimulating hormone normal

• T4 normal

• Triglycerides ≤ 1.5 times ULN

• No malignancy within the past 5 years except breast cancer or basal cell or squamous cell skin cancer

• No evidence of recurrent disease

• No known or suspected hypersensitivity to blood, blood products, or albumin

• No undiagnosed genital bleeding

• No history of pancreatitis

• No uncontrolled diabetes

• No other severe underlying chronic disease

• No concurrent alcohol use (> 3 drinks/day or equivalent)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 3 months since prior chemotherapy for breast cancer

Endocrine therapy

• No concurrent selective estrogen-receptor modulators, including raloxifene

• No concurrent aromatase inhibitors

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• More than 3 months since prior therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin)

• No other concurrent investigational agents

• No concurrent cyclooxygenase-2 (COX-2) inhibitors

• No concurrent oral vitamin A or ascorbic acid (vitamin C) supplements > recommended daily requirement (10,000 IU for vitamin A and 75 mg for vitamin C)