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


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Mary B. Daly, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068655

NCT ID:

NCT00017134

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Mount Sinai Medical CenterNew York, New York  10029
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Colorado Gynecologic Oncology Group P.C.Aurora, Colorado  80010
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
George Bray Cancer Center at New Britain General HospitalNew Britain, Connecticut  06050