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Home > "F" Clinical Trials Conditions > Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk

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



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

For Condition: ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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 receive oral fenretinide daily on days 1-27. Treatment repeats every 30 days for 4-6 courses in the absence of unacceptable toxicity or diagnosis of malignancy. After completion of fenretinide, patients undergo prophylactic oophorectomy. - Arm II: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 AND 1 or more first or second-degree relatives diagnosed with breast or ovarian cancer - 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 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 of nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 6 months since prior chemotherapy - No prior chemotherapy for malignancy Endocrine therapy: - At least 6 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 6 months since prior radiotherapy - No prior radiotherapy to pelvis for malignancy Surgery: - See Disease Characteristics Other: - At least 6 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) more than 3 times per month within the past 6 months - No concurrent NSAIDs more than 3 times per month
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MaryDaly,  Study Chair,  Fox Chase Cancer Center

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting S.  Yamada 773-702-6722

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Andrew  Menzin 516-562-4438

Saint Joseph Regional Medical Center *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Michael  Method 574-237-8010

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Shashikant  Lele 716-845-5776

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Mark  Morgan 215-662-6043

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda,  Maryland,  20892-1182
United States
Recruiting Patient  Recruitment 1-888-NCI-1937

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80010
United States
Recruiting Francis  Major 303-388-4876

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5001
United States
Recruiting G.  Rose 202-782-8515

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1740
United States
Recruiting Jonathan  Berek 310-206-5161

Cancer Center at the University of Virginia *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting Willie  Andersen 434-924-9333

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Katherine  Look 317-274-8987

Tufts - New England Medical Center *Recruiting*
Boston,  Massachusetts,  02111
United States
Recruiting Kenneth  Noller 617-636-2382

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Nava  Siegelmann-Danieli 570-271-6834

Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook,  New York,  11790-7775
United States
Recruiting Michael  Pearl 631-444-2774

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Stephanie  King 215-762-2640

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting David  Mutch 314-362

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Charles  Levenback 713-745-2563

Cancer Center of Albany Medical Center *Recruiting*
Albany,  New York,  12208
United States
Recruiting Henry  Keys 518-262-6713

Tom Baker Cancer Center - Calgary *Recruiting*
Calgary,  Alberta,  T2N 4N2
Canada
Recruiting Gavin  Stuart 403-944-1721

Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago,  Illinois,  60612-3824
United States
Recruiting Howard  Strassner 312-942-6723

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Linda  Carson 612-626-3347

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos,  California,  95032
United States
Recruiting Nick  Spirtos 408-866-3843

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390-9032
United States
Recruiting David  Miller 214-648-3026

Gynecologic Oncology Network *Recruiting*
Nashville,  Tennessee,  37203
United States
Recruiting Howard  Homesley 615-804-2216

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Wesley  Fowler 919-966-1196

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1002
United States
Recruiting Joel  Sorosky 319-356-2015

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62794-9640
United States
Recruiting L.  Massad 217-545-8882

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Tacoma General Hospital *Recruiting*
Tacoma,  Washington,  98405
United States
Recruiting Roger  Lee 253-403-1029

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Cheung  Wong 802-847-5110

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109-1024
United States
Recruiting Benjamin  Greer 206-685-2463

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44124
United States
Recruiting Peter  Rose 216-444-1712

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-2516
United States
Recruiting Marta  Crispens 615-322-2114

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Mack  Barnes 205-934-0930

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Sara  Crowder 573-882-1057

Abington Memorial Hospital *Recruiting*
Abington,  Pennsylvania,  19001-3788
United States
Recruiting Parviz  Hanjani 215-885-0220

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0587
United States
Recruiting Edward  Hannigan 409-772-3368

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anthony  Evans 715-389-3101

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Australia New Zealand Gynaecological Oncology Trials Group *Recruiting*
Camperdown,  New South Wales,  1450
Australia
Recruiting Michael  Friedlander 61-2-9562-1450

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Frederick  Ueland 606-257-1613

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Steven  Waggoner 216-844-5011

University of Oklahoma College of Medicine *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting Robert  Mannel 405-271-8787

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Carol  Brown 212-639-7659

State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook,  New York,  11794
United States
Recruiting Michael  Pearl 631-444-2774

Magee-Womens Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15213-3180
United States
Recruiting Joseph  Kelley 412-641-5418

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Daniel  Clarke-Pearson 919-684-3765

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Gunter  Deppe 313-745-7286

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01605-2982
United States
Recruiting Susan  Zweizig 508-334-1160

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111
United States
Recruiting Michael  Bookman 215-728-2987

Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Kenneth  Cofer 865-673-9250

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0526
United States
Recruiting Nader  Husseinzadeh 513-558-8450

Norwegian Radium Hospital *Recruiting*
Oslo,  ,  N-0310
Norway
Recruiting Gunnar  Kristensen 47-22-934-000

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Jeffrey  Fowler 614-293-8737

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Robert  Burger 714-456-7971

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905-0001
United States
Recruiting Harry  Long 507-284-4320

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting George  Olt 717-531-8144

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1065
United States
Recruiting Brigitte  Miller 336-716-6673

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103-1489
United States
Recruiting David  Warshal 856-342-2185

H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa,  Florida,  33612-9497
United States
Recruiting James  Fiorica 813-972-8478


Additional Information:
Study ID Numbers:
  CDR0000068655;  GOG-0190
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017134

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

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