Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer
Open label single arm phase II study of cisplatin and irinotecan in patients with advanced
gastric carcinoma not previously treated with palliative chemotherapy. 40 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: 8 cycles/14 days of
irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include
genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of
efficacy and toxicity of the treatment with cisplatin and irinotecan in the study
population.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
The primary objective of this study is to determine the response rate of CPT11 plus cisplatin as first-line therapy in patients with advanced gastric carcinoma.
1 year
Yes
Jing Huang, M.D.,Ph.D
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Ministry of Health
CH-GI-017
NCT01444521
April 2011
December 2012
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