Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk

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: NCT00017134
Recruitment Status : Terminated (Withdrawn due to poor accrual)
First Posted : May 7, 2003
Last Update Posted : June 10, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: fenretinide Procedure: conventional surgery Not Applicable

Detailed Description:


  • 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 undergo prophylactic oophorectomy.
  • Arm II: 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.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Primary Purpose: Prevention
Official Title: An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
Study Start Date : September 2002
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 (any age) 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
  • Meets any 1 of the following criteria:

    • Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast* and/or ovarian cancer
    • Ashkenazi Jewish ethnicity with diagnosed breast* cancer in patient
    • Greater than 20% probability of carrying BRCA1/2 mutation with a family history of breast and ovarian cancer NOTE: * Where breast cancer is required to meet this criteria, diagnosis must occur prior to menopause or at ≤ 50 years old if age at menopause is unknown
  • Planned prophylactic oophorectomy
  • Normal pelvic exam within the past 6 weeks



  • 18 and over

Performance status:

  • GOG 0-1

Life expectancy:

  • At least 12 months


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal (ULN)


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Triglyceride less than 2 times ULN (fasting)


  • No myocardial infarction within the past 3 months
  • No active angina
  • No unstable heart rhythms
  • No clinically evident congestive heart failure


  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 3 months since prior radiotherapy
  • No prior radiotherapy to pelvis for malignancy


  • See Disease Characteristics


  • 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
  • Concurrent aspirin at a dose of 81 mg/day allowed

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): NCT00017134

  Show 35 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Mary B. Daly, MD, PhD Fox Chase Cancer Center Identifier: NCT00017134     History of Changes
Other Study ID Numbers: CDR0000068655
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: November 2006

Keywords provided by Gynecologic Oncology Group:
ovarian epithelial cancer

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