Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Trial Identification
Brief Title: Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official Title: A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study ID: NCT00023699
Interventions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Community Hospital of Los Gatos, Los Gatos, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Medical Oncology Clinical Research Unit, Bethesda, Maryland, United States
Tufts University School of Medicine, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, 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
Schneider Children's Hospital at North Shore, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, 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
University of Birmingham, Birmingham, England, United Kingdom
Contact Details
Name: Russell J. Schilder, MD
Affiliation: Fox Chase Cancer Center
Role: STUDY_CHAIR
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