Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
- Conditions
- Cervical Cancer
- Registration Number
- NCT00006482
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. 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: A total of 28-69 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- 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 (34)
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Rational Therapeutics Inc.
🇺🇸Long Beach, California, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Illinois College of Medicine at Peoria
🇺🇸Peoria, Illinois, 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
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States