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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017134 |
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 |
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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.
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:
Study Chair: | Mary B. Daly, MD, PhD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068655, GOG-0190 |
Study First Received: | June 6, 2001 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00017134 |
Health Authority: | United States: Food and Drug Administration |
ovarian epithelial cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Carcinoma Genital Diseases, Female Endocrinopathy Fenretinide Endocrine Gland Neoplasms |
Anticarcinogenic Agents Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Protective Agents Pharmacologic Actions Adnexal Diseases |