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

Ovarian Cancer Clinical Trial

Official title:

An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00017134
• Other study ID #: CDR0000068655
• Secondary ID: GOG-0190
• Status: Terminated
• Phase: N/A
• First received: June 6, 2001
• Last updated: June 7, 2013
• Start date: September 2002

Study information

• Verified date: November 2006
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 undergo prophylactic oophorectomy.

• Arm II: Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8 weeks. Treatment continues in the absence of unacceptable toxicity or diagnosis of malignancy. After completion of fenretinide, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 (any age) AND 1 or more first- or second-degree relatives diagnosed with breast or ovarian cancer

• Personal history of breast cancer (at any age) AND 1 or more first- or second-degree relative diagnosed with breast or ovarian cancer at any age

• Meets any 1 of the following criteria:

• Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast* and/or ovarian cancer

• Ashkenazi Jewish ethnicity with diagnosed breast* cancer in patient

• Greater than 20% probability of carrying BRCA1/2 mutation with a family history of breast and ovarian cancer NOTE: * Where breast cancer is required to meet this criteria, diagnosis must occur prior to menopause or at = 50 years old if age at menopause is unknown

• 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 (fasting)

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 or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 months since prior chemotherapy

Endocrine therapy:

• At least 3 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 3 months since prior radiotherapy

• No prior radiotherapy to pelvis for malignancy

Surgery:

• See Disease Characteristics

Other:

• At least 3 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) on a regular (chronic or daily) basis within the past 6 months

• No concurrent NSAIDs on a regular (chronic or daily) basis

• Concurrent aspirin at a dose of 81 mg/day allowed

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• fenretinide

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Colorado Gynecologic Oncology Group P.C.	Aurora	Colorado
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	University of Minnesota Medical Center & Children's Hospital - Fairview	Minneapolis	Minnesota
United States	George Bray Cancer Center at New Britain General Hospital	New Britain	Connecticut
United States	Mount Sinai Medical Center	New York	New York
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Oregon Health & Science University Cancer Institute	Portland	Oregon
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,