A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: XELIRI+ bevacizumab Capecitabine:2000mg/m2/day d1‐8 Irinotecan:180mg/m2 d1 Bevacizumab:5mg/kg d1 Q2w CONDITION: colorectal cancer PRIMARY OUTCOME: Phase I part; To determine Safety in 1st cycle by Bi‐weekly XELIRI+bevacizumab.; Phase II part; Progression Free Survival SECONDARY OUTCOME: Phase II; Safety; response rate INCLUSION CRITERIA: 1)Written informed consent 2) Age: 20‐75 years old. 3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 4) Life expectancy greater than or equal to 3 months 5) Confirmed wild or hetero of UGT1A1*6*28 genotype. 6)Histological confirmation of colorectal cancer. 7) Unresectable primary tumor or with one or more unresectable metatatic tumor Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) 8) Progression during or after first‐line chemotherapy for metastatic disease, including Oxaliplatin‐based chemotherapy with bevacizumab 9) Vital organ functions (listed below) are preserved within 2 weeks prior to entry i. Neurtophils>=2000/mm3 ii. Platelets>=100,000/mm3 iii. Hemoglobin>=9.0g/dl iv. Total bilirubin>=upper limit of normal (ULN)*1.5 v. AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) vi. Serum creatinine
Epistemonikos ID: 0b7374e9bb6eefc71386a36236c0f01c012aab55
First added on: Aug 22, 2024