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

June 7, 2013 updated by: Gynecologic Oncology Group

An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Anticipated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Colorado Gynecologic Oncology Group P.C.
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at New Britain General Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    • Illinois
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Northwestern Healthcare - Evanston Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center & Children's Hospital - Fairview
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
    • Ohio
      • Akron, Ohio, United States, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    • Texas
      • Galveston, Texas, United States, 77555-0361
        • University of Texas Medical Branch
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-1

Life expectancy:

  • At least 12 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mary B. Daly, MD, PhD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068655
  • GOG-0190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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