Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer|
- Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
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
|Study Start Date:||April 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|