Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00041236|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: exatecan mesylate||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041236
|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 Klinik|