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 gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
OBJECTIVES: * Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. * Determine the nature and degree of toxicity of this regimen in this patient population. * Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients. * Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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Community Hospital of Los Gatos
Los Gatos, California, 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
Ellis Fischel Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
...and 21 more locations