NCT00708812

Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer

Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Endostar(Recombinant Human Endostatin Injection)	Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
DRUG	paclitaxel-carboplatin	paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-07-02
• Last updated: 2011-07-21

Locations

1 site across 1 country: China