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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098800
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : March 24, 2010
National Cancer Institute (NCI)
Information provided by:
University of Arizona

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 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.

Condition or disease Intervention/treatment Phase
brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer Drug: fenretinide Not Applicable

Detailed Description:



  • 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 vs placebo.


  • Compare modulation of several intermediate markers (TGFβ, BAX, Ki-67, ER, PR, RARβ, TGFβRI, TGFβRII, p21, p53, FAS, and FASL) in participants treated with these regimens.
  • Compare early microvascular changes, using contrast-enhanced ultrasound, in participants treated with these drugs.
  • Determine whether the use of contrast agents could indicate changes in ovarian size and architecture that may be assessed as potential surrogates for preventive effect in these participants.
  • Determine the feasibility of future chemoprevention trials for ovarian cancer.
  • Determine the toxicity of fenretinide in these participants.
  • Compare the microvascularity index and ovarian volume of participants treated with these drugs.
  • Correlate areas of increased microvascularity and other abnormalities with pathology findings obtained at oophorectomy in participants treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are randomized to 1 of 2 treatment arms.

  • Arm I: Participants receive oral fenretinide once daily.
  • Arm II: Participants receive oral placebo once daily. In both arms, treatment continues for 6-8 weeks in the absence of unacceptable toxicity.

Within 5 days after completion of fenretinide or placebo, participants undergo bilateral salpingo-oophorectomy.

Participants are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 40 participants (20 per treatment arm) will be accrued for this study within 4 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer: Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in High-Risk Women Using Fenretinide (4-HPR)
Study Start Date : October 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 30 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • At least 12 months


  • Not specified


  • 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


  • BUN normal
  • Creatinine normal


  • 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


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


  • 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)


Biologic therapy

  • Not specified


  • At least 3 months since prior chemotherapy for breast cancer

Endocrine therapy

  • No concurrent selective estrogen-receptor modulators, including raloxifene
  • No concurrent aromatase inhibitors


  • Not specified


  • See Disease Characteristics


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00098800

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Principal Investigator: Molly A. Brewer, MD, DVM, MS University of Arizona Identifier: NCT00098800     History of Changes
Other Study ID Numbers: CDR0000396796
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: November 2006

Keywords provided by University of Arizona:
ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders