A Phase 2 interventional study of irinotecan and cisplatin in Gastric Cancer, sponsored by Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-06.
Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.
Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.
Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).
Exclusion Criteria:
Drug: irinotecan and cisplatin
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.
Also known as: CAMPT
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 study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences