Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer
|ClinicalTrials.gov Identifier: NCT01444521|
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : May 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: irinotecan and cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
|Experimental: single-arm Irinotecan-Cisplatin||
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.
Other Name: CAMPT
- Overall response rate [ Time Frame: 1 year ]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 to event efficacy [ Time Frame: 1 year ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444521
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Beijing, China, 100021|
|Principal Investigator:||Jing Huang, M.D.,Ph.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|