Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention, Treatment Closed 18 and over NCI GOG-0190 NCT00017134

Objectives

1. 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.
2. Determine the relative abundance of markers of cell proliferation and apoptosis in cancer-prone ovaries of patients treated with fenretinide.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-1

Life expectancy:

• At least 12 months

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 71 patients will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Mary Daly, MD, PhD, Protocol chair		Ph: 215-728-2705; 888-369-2427 Email: mary.daly@fccc.edu

Registry Information
Official Title		An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
Trial Start Date		2002-09-03
Registered in ClinicalTrials.gov		NCT00017134
Date Submitted to PDQ		2001-04-09
Information Last Verified		2006-11-14
NCI Grant/Contract Number		CA27469

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