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Brief Title: Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
Official Title: A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Study ID: NCT00006482
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 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
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 Illinois College of Medicine at Peoria, Peoria, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Tufts University School of Medicine, Boston, Massachusetts, United States
University of Mississippi Medical Center, Jackson, Mississippi, 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
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
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Tacoma General Hospital, Tacoma, Washington, United States
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Name: Cheryl A. Brewer, MD
Affiliation: University of Illinois College of Medicine at Peoria
Role: STUDY_CHAIR