Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: TS‐1+Irinotecan+Bevacizumab therapy Bevacizumab 7.5mg/m2/tri‐weekly Irinotecan 150mg/m2/tri‐weekly TS‐1 80‐120mg/day, for 14 days followed by 1 week rest CONDITION: Metastatic colorectal cancer PRIMARY OUTCOME: 6‐Month Progression Free Survival Rate SECONDARY OUTCOME: Overall Survival; Progression Free Survival; Response Rate; Safety INCLUSION CRITERIA: (1)Patients with histologically proven colorectal cancer (2)Metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy as first‐line (3)Presence of evaluable lesion (4)ECOG Performance Status 0‐1 (5)Age equal more 20 years old (6)Life expectancy of more than 3 months (7)Oral food intake possible (8)Patiens have enough organ function for study treatment within 14 days before enrollment WBC>=3,000/mm3, <12,000/mm3 Neu>=1,500/mm3 PLT>=10.0x104/mm3 Hb>=9.0g./dL Total Bilirubin <= 1.5mg/dL AST<=100 IU/L ALT<=100 IU/L Creatinine <=1.2mg/dL Creatinine clearance >=50mL/min Proteinuria<=2+ PT‐INR <=1.5 (9)Written informed consent
Epistemonikos ID: 78fb1b76e9c39e502438e8746841b9c872a180e0
First added on: Aug 22, 2024