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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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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 D.C., 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
...and 24 more locations