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OPAXIO™ (paclitaxel poliglumex, CT-2103)
Studies in Lung Cancer
Women and Lung Cancer
Lung cancer is the leading cause
of cancer death worldwide. Among females, the incidence of lung
cancer continues to increase, killing more women than breast, ovarian, and
cervical cancers combined.
Recent in vivo studies indicate that OPAXIO metabolism
by some cancer cells is enhanced in the presence of estrogen, which leads
to increased levels of paclitaxel in tumor tissue and greater anti-tumor
effects.
The efficacy of OPAXIO as a first-line treatment
in advanced NSCLC was evaluated in our STELLAR 3 and 4 trials.
The composite analysis showed a statistically significant survival benefit
for women receiving OPAXIO (198 patients) compared
to the control arms, where men treated with OPAXIO did
similarly to men treated with comparator agents.
Clinical Trials for Women with NSCLC
A phase III clinical trial, known as PGT307, is currently recruiting women
with advanced NSCLC who have pre-menopausal estrogen levels (> 30pg/mL) – a
group who’s survival is significantly shorter than post-menopausal
women. We received Special Protocol Assessment (SPA) approval from
the FDA on the design of the trial.
This phase III trial is expected
to enroll 450 patients. Each study arm of approximately 225 patients
will be randomized to receive either OPAXIO plus
carboplatin, or paclitaxel plus carboplatin once every three weeks.
Patients will be treated for up to six cycles. The primary endpoint
is superior overall survival with several secondary endpoints including
progression-free survival, disease control, clinical benefit, response
rate, quality of life, and the safety and tolerability of the treatment
arms.
OPAXIO™
Fact Sheet (226k PDF)
Posted May 13, 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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