Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Peter Reichardt, MD
Study Chair
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
United States: Federal Government
EORTC-62006
NCT00041236
May 2002
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