Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00005031
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.
- Detailed Description
OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma. II. Determine the nature and degree of toxicity of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
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 (40)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, 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
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States