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Lung Cancer Clinical Trial - PGT307
XYOTAX (paclitaxel poliglumex, CT-2103) in combination with
carboplatin for the treatment of chemotherapy-naive advanced
non-small cell lung cancer (NSCLC) in women with estradiol
greater than 30 pg/mL
Would you like more information?
Please email Medical
Information Inquiries,
or from the U.S. call 1-800-715-0944 for
more information about this trial.
Find
the cancer research clinical
trial location in the United States nearest you. >
What is XYOTAX (CT-2103)?
XYOTAX™ (Zi-o-taks) is a biologically-enhanced
chemotherapeutic that links paclitaxel, the active ingredient
in Taxol®,
to a biodegradable polyglutamate
polymer, which results in a new chemical entity. More
>>
How is this lung cancer study conducted?
This is a multinational, phase III open-label study of patients randomized
to one of two arms.
The primary objective of this study
is to compare the overall survival of patients randomized
to the CT-2103/carboplatin arm to that of patients randomized
to the comparator arm, paclitaxel/carboplatin. Seconday
objectives are to compare the progression-free survivial,
disease control, clinical benefit, response rate, quality
of life, and the safety and tolerability of the treatment
arms.
Who can participate in this lung cancer clinical trial?
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Adult women with histologically- or cytologically-confirmed
diagnosis of advanced NSCLC with measurable or nonmeasurable
disease |
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Baseline estradiol greater than 30 pg/mL (women on hormone replacement
therapy are allowed) |
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Performance status 0, 1, or 2 |
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No prior chemotherapy for NSCLC |
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Patients must have either recurrent disease following radiation
or surgery, stage IIIB disease in patients who are not
candidates for combined modality therapy, or stage IV disease |
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Those patients with known brain metastases must have recovered
from therapy for their CNS metastases and must have stable neurologic
function for at least 2 weeks before randomization. |
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Adequate bone marrow, renal, hepatic, and cardiac function |
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Other criteria that the study physician will evaluate |
Taxol® is a registered trademark of Bristol-Myers
Squibb Co.
Posted Nov. 28, 2007
Copyright © 2004-2007 Cell Therapeutics, Inc., Seattle,
WA, USA. All rights reserved. "Making cancer more treatable" is
a registered mark of CTI.
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