Fenretinide in Preventing Ovarian Cancer in Participants Who Are at High Risk for Developing Ovarian Cancer and Planning to Undergo Surgery to Remove the Ovaries

NCT00098800 | Completed

• 5 other identifiers: CDR0000396796P30CA016672UARIZ-GYN-01021UARIZ-HSC-02190MDA-GYN-01021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fenretinide may prevent ovarian cancer. PURPOSE: This randomized clinical trial is studying how well fenretinide works in preventing ovarian cancer in participants who are at high risk of developing ovarian cancer and planning to undergo surgery to remove the ovaries.

Conditions

brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer

Keywords

ovarian epithelial cancer; BRCA1 mutation carrier; BRCA2 mutation carrier

Interventions

fenretinide DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At high risk for developing ovarian cancer, meeting 1 of the following criteria: * Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer before 50 years of age * Family history of ovarian cancer, defined as ≥ 1 first-degree relative diagnosed with ovarian cancer at any age AND ≥ 1 first- or second-degree relative diagnosed with breast or ovarian cancer at any age * Positive BRCA1/BRCA2 test * Planning to undergo prophylactic bilateral oophorectomy PATIENT CHARACTERISTICS: Age * 30 and over Performance status * Zubrod 0-1 Life expectancy * At least 12 months Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * No history of liver disease\* * No cholestatic jaundice * No hepatic adenomas NOTE: \*For patients undergoing contrast enhanced ultrasound Renal * BUN normal * Creatinine normal Cardiovascular * No history of a congenital heart defect creating a bi-directional or right-to-left shunt\* * No history of congestive heart failure\* * No thrombophlebitis * No thromboembolic disease * No cerebral vascular disease * No coronary artery disease NOTE: \*For patients undergoing contrast enhanced ultrasound Pulmonary * No history of pulmonary hypertension\* * No history of pulmonary emboli\* * No history of severe emphysema\* NOTE: \*For patients undergoing contrast enhanced ultrasound Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * Thyroid stimulating hormone normal * T4 normal * Triglycerides ≤ 1.5 times ULN * No malignancy within the past 5 years except breast cancer or basal cell or squamous cell skin cancer * No evidence of recurrent disease * No known or suspected hypersensitivity to blood, blood products, or albumin * No undiagnosed genital bleeding * No history of pancreatitis * No uncontrolled diabetes * No other severe underlying chronic disease * No concurrent alcohol use (\> 3 drinks/day or equivalent) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 3 months since prior chemotherapy for breast cancer Endocrine therapy * No concurrent selective estrogen-receptor modulators, including raloxifene * No concurrent aromatase inhibitors Radiotherapy * Not specified Surgery * See Disease Characteristics Other * More than 3 months since prior therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin) * No other concurrent investigational agents * No concurrent cyclooxygenase-2 (COX-2) inhibitors * No concurrent oral vitamin A or ascorbic acid (vitamin C) supplements \> recommended daily requirement (10,000 IU for vitamin A and 75 mg for vitamin C)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Molly A. Brewer, MD, DVM, MS

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: October 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 24, 2010

Record last verified: 2006-11

Locations

US (1)