Ovarian Cancer Clinical Trial

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

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

71

Study ID:

NCT00017134

Recruitment Status:

Terminated

Sponsor:

Gynecologic Oncology Group

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There are 35 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

71

Study ID:

NCT00017134

Recruitment Status:

Terminated

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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