Status:
COMPLETED
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
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
brca1 Mutation Carrier
brca2 Mutation Carrier
Eligibility:
FEMALE
30+ years
Phase:
NA
Brief 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...
Detailed Description
OBJECTIVES: Primary * Compare the induction of apoptosis (as determined by TUNEL) in the ovarian epithelial and stromal cells of participants at high risk for ovarian cancer treated with fenretinide...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00098800
Start Date
October 1 2004
End Date
November 1 2006
Last Update
March 24 2010
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024