Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00023699
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
* Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
* Determine the nature and degree of toxicity in patients treated with this drug.
* Determine the partial and complete response rates in patients treated with this drug.
* Determine the duration of progression-free and overall survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Schneider Children's Hospital at North Shore
🇺🇸Manhasset, New York, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Medical Oncology Clinical Research Unit
🇺🇸Bethesda, Maryland, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Australia New Zealand Gynaecological Oncology Trials Group
🇦🇺Camperdown, New South Wales, Australia
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Fletcher Allen Health Care - Medical Center Campus
🇺🇸Burlington, Vermont, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Birmingham
🇬🇧Birmingham, England, United Kingdom
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States