Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group|
|Study Start Date:||May 2002|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
- 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.
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Leuven, Belgium, B-3000|
|Aarhus University Hospital - Aarhus Sygehus - Norrebrogade|
|Aarhus, Denmark, DK-8000|
|Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch|
|Berlin, Germany, D-13122|
|Universitatsklinikum Carl Gustav Carl Carus|
|Dresden, Germany, D-01307|
|Essen, Germany, D-45122|
|Hamburg, Germany, D-20246|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Eberhard Karls Universitaet|
|Tuebingen, Germany, D-72076|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 833 10|
|Study Chair:||Peter Reichardt, MD||Robert Roessle Comprehensive Cancer Center - Charite Campus Buch|