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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: | Allocation: Randomized Primary Purpose: Prevention |
| 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
Show 35 Study Locations| Study Chair: | Mary B. Daly, MD, PhD | Fox Chase Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00017134 History of Changes |
| Other Study ID Numbers: | CDR0000068655, GOG-0190 |
| Study First Received: | June 6, 2001 |
| Last Updated: | March 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian epithelial cancer |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |