A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin
Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent
or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The
primary objective of this study is to determine the response rate of the treatment.Schedule
for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous
infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will
also include the investigation of ERCC1 expression in order to assess determinants of
efficacy of the treatment with cisplatin and paclitaxel in the study population.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR)
The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma
5 year
Yes
Jing Huang, M.D.,Ph.D
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Beijing Municipal Science and Technology Commission
CH-GI-021
NCT01444547
January 2007
October 2013
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