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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
OBJECTIVES: * Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma. * Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies). Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival. PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Cliniques Universitaires Saint-Luc
Brussels, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, Denmark
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Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany
Universitatsklinikum Carl Gustav Carl Carus
Dresden, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Eberhard Karls Universitaet
Tübingen, Germany
National Cancer Institute - Bratislava
Bratislava, Slovakia