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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017134 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: fenretinide Procedure: conventional surgery |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Active Control |
| Official Title: | An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma |
| Estimated Enrollment: | 71 |
| Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Increased risk for ovarian cancer secondary to 1 of the following:
Meets any 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| United States, Colorado | |
| Colorado Gynecologic Oncology Group P.C. | |
| Aurora, Colorado, United States, 80010 | |
| United States, Connecticut | |
| George Bray Cancer Center at New Britain General Hospital | |
| New Britain, Connecticut, United States, 06050 | |
| Helen and Harry Gray Cancer Center at Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| United States, Florida | |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Illinois | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| United States, Indiana | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0293 | |
| United States, Michigan | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| University of Minnesota Medical Center & Children's Hospital - Fairview | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| St Louis, Missouri, United States, 63110 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, Ohio | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Hillcrest Cancer Center at Hillcrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health & Science University Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |
| Allentown, Pennsylvania, United States, 18105 | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0361 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Study Chair: | Mary B. Daly, MD, PhD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000068655, GOG-0190 |
| Study First Received: | June 6, 2001 |
| Last Updated: | March 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017134 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian epithelial cancer |
|
Anticarcinogenic Agents Ovarian Neoplasms Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Protective Agents Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Fenretinide Endocrine Gland Neoplasms |