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

18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

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


- 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

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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Mary B. Daly, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms



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