Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00487669
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00487669
Study Brief:
Protocol Section:
NCT00487669