Advanced Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-small Cell Lung Cancer.
This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.
Primary objective
To evaluate the overall response rate (complete plus partial responses by RECIST criteria)
to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with
advanced NSCLC.
Secondary Objectives
To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex
and pemetrexed as therapy in patients with advanced NSCLC.
To evaluate the duration of response, time to progression, and overall survival of advanced
NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.
To compare the overall response rate using three-dimensional reconstruction of target
lesions by Medical Metrx Solutions (MMS) and RECIST criteria.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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