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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fenretinide
conventional surgery
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Cancer focused on measuring ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • Colorado Gynecologic Oncology Group P.C.
  • Helen and Harry Gray Cancer Center at Hartford Hospital
  • George Bray Cancer Center at New Britain General Hospital
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • Evanston Northwestern Healthcare - Evanston Hospital
  • St. Vincent Indianapolis Hospital
  • Memorial Hospital of South Bend
  • Holden Comprehensive Cancer Center at University of Iowa
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • William Beaumont Hospital - Royal Oak Campus
  • University of Minnesota Medical Center & Children's Hospital - Fairview
  • CCOP - Metro-Minnesota
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Roswell Park Cancer Institute
  • Mount Sinai Medical Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Blumenthal Cancer Center at Carolinas Medical Center
  • McDowell Cancer Center at Akron General Medical Center
  • Charles M. Barrett Cancer Center at University Hospital
  • Riverside Methodist Hospital Cancer Care
  • Mount Carmel Health - West Hospital
  • Hillcrest Cancer Center at Hillcrest Hospital
  • Oklahoma University Medical Center
  • Oregon Health & Science University Cancer Institute
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • University of Texas Medical Branch
  • Fletcher Allen Health Care - University Health Center Campus
  • Virginia Commonwealth University Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017134
Brief Title
Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
Official Title
An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to poor accrual
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian epithelial cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fenretinide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary B. Daly, MD, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Colorado Gynecologic Oncology Group P.C.
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Helen and Harry Gray Cancer Center at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
George Bray Cancer Center at New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Evanston Northwestern Healthcare - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Minnesota Medical Center & Children's Hospital - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Hillcrest Cancer Center at Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0361
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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