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The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy

Clinical Trial Summary

Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).

As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.

Clinical Trial Description

Primary end point: Objective Response Rate(ORR)

Secondary end point:

Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02262897
Study type Interventional
Source Tongji University
Contact Shengxiang Ren
Email harry_ren@126.com
Status Recruiting
Phase Phase 2
Start date September 2013
Completion date May 2016
View Details
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