NCT00813332

Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)

A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.

Detailed description

The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for this indication. However, there are limited data on the safety and efficacy of Endostar in combination with other widely used chemotherapy doublets for NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. In this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv, d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to NSCLC and hope to provide a promising regimen to advanced lung cancer patients.

Conditions

• Advanced NSCLC
• Recurrent NSCLC

Interventions

Type	Name	Description
DRUG	Endostar(rh recombinant endostatin) plus Docetaxel	7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
DRUG	Placebo plus Docetaxel	Placebo plus Docetaxel

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-10-01
• Completion: 2010-10-01
• First posted: 2008-12-23
• Last updated: 2010-01-25

Locations

1 site across 1 country: China