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

This study has been terminated.
(Withdrawn due to poor accrual)
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00017134
First received: June 6, 2001
Last updated: June 7, 2013
Last verified: November 2006
  Purpose

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 Intervention
Ovarian Cancer
Drug: fenretinide
Procedure: conventional surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 71
Study Start Date: September 2002
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017134

  Show 35 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Mary B. Daly, MD, PhD Fox Chase Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00017134     History of Changes
Other Study ID Numbers: CDR0000068655, GOG-0190
Study First Received: June 6, 2001
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gynecologic Oncology Group:
ovarian epithelial cancer

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

ClinicalTrials.gov processed this record on October 22, 2014