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Lung Cancer Clinical Trial - PGT307

OPAXIO™ (paclitaxel poliglumex, CT-2103; formerly known as XYOTAX) 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

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Please email Medical Information Inquiries, or from the U.S. call 1-800-715-0944 for more information about this trial.

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What is OPAXIO?

OPAXIO 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?
• Adult women with histologically- or cytologically-confirmed diagnosis of advanced NSCLC with measurable or nonmeasurable disease
• Baseline estradiol greater than 30 pg/mL (women on hormone replacement therapy are allowed)
• Performance status 0, 1, or 2
• No prior chemotherapy for NSCLC
• 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
• 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.
• Adequate bone marrow, renal, hepatic, and cardiac function
• Other criteria that the study physician will evaluate


Taxol® is a registered trademark of Bristol-Myers Squibb Co.

Posted May 20, 2008

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