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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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    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024