A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar(rh Recombined Endostatin)With Single Docetaxel In NSCLC Patients
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression-free survival time,survival rate for 1 year
two years (2010.10)
No
Kai LI, professor
Principal Investigator
Cancer Hospital of Tianjin Medical University
China: Food and Drug Administration
simcere002
NCT00813332
October 2008
October 2010
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