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Sarcoma Clinical Trial (SMI-BRS-203)
Randomized phase II study of brostallicin (PNU-166196A) versus doxorubicin
as first-line chemotherapy in patients with advanced
or metastatic soft tissue sarcoma
The primary objective of this study is to evaluate the activity and
safety of brostallicin as first-line chemotherapy in patients with advanced
or metastatic soft tissue sarcoma.
What is brostallicin?
Brostallicin (bräst-al-iss-in) is a new class of
cancer drug — a synthetic DNA minor
groove binding agent. We are developing brostallicin
for the treatment of advanced
or metastatic soft tissue sarcoma. More
>>
How is this soft tissue sarcoma study conducted?
This soft tissue sarcoma study is a randomized phase II trial.
Who can participate in this soft tissue sarcoma clinical trial?
The following criteria (along with other technical criteria) must be
evaluated by the study physician: |
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Histologically or cytologically confirmed high or intermediate
grade malignant soft tissue sarcoma |
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Relapsed or refractory disease incurable by surgery or radiotherapy;
evidence of objective progression within the last 6 months |
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Presence of measurable disease (RECIST criteria) |
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No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant
therapy is allowed |
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At least 60 years of age, or patients at least 18 years of age non-suitable
for intensive chemotherapy combination treatments |
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WHO performance status 0 or 1 |
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Absence of symptomatic or known CNS metastases |
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Adequate bone marrow, hepatic and renal function |
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Clinical normal cardiac function |
For
more information on this soft tissue sarcoma clinical trial, view
the EORTC Web site
Posted March 18, 2008
Copyright © 2004-2008 Cell Therapeutics, Inc., Seattle,
WA, USA. All rights reserved. "Making cancer more treatable" is
a registered mark of CTI.
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