The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
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.
Time frame: 1 year
Time to event efficacy
The secondary objectives of this study are to evaluate: The following time to event efficacy measures: * Duration of overall response for responding patients * Time to documented progressive disease * Overall survival * The quantitative and qualitative toxicity of irinotecan plus cisplatin. * Determinants of efficacy and toxicity of the treatment with irinotecan and cisplatin in the patient population by means of pharmacogenomic investigations: Quantitative analysis of UGT1A1 and ERCC1
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.