Colorectal cancer
Conditions
Interventions
mFOLFOX6 (-BEV): On Day1, iv infusion of 85 mg/m2 of l-OHP and 175 mg/m2 of L-LV for 2hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 cou
Sponsors
Personalized Medicine Study Group for Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) Stage IV unresectable case. 3) The patient must have measurable disease (RECIST) 4) Patient must have appropriate organ function (bone marrow, liver, kidney, cardiac, etc.) and the laboratory value within 7 days before the protocol treatment must be WBC 4,000/mm3 or more ANC 2,000/mm3 or more Platelet 100,000/mm3 or more Hemoglobin 9.0g/dl or more AST, ALT x2 institutional ULN or less (For the liver metastatic cases, x3 institutional ULN or less) Serum Total Bilirubin 1.5 mg/dL or less Serum Creatinine 1.5 mg/dL or less Creatinine clearance 60 ml/min or more BUN 25mg/dl or less ECG Normal 5) ECOG Performance Status 0-2 6) Any therapy should not have been given for the current disease. 7) Protocol treatment must be started within 6 weeks after surgery. 8) Collected tissue sample must be enough for genomic analysis. 9) Life expectancy must be 12 weeks or more at the time of registration. 10) Age 20 years or older 11) Written informed consent must be obtained for the study including blood or tissue sampling.
Exclusion criteria
Exclusion criteria: 1) Patients with obvious infectious disease. 2) Patients with watery diarrhea. 3) Patients with intestinal paralysis, obstruction, or subobstruction of bowel (At the time of registration) 4) Patients with interstitial pneumonia or pulmonary fibrosis 5) Patients with considerable cancerous body cavity fluid. 6) Patients with severe paresthesia of functional disorder or dysesthesia 7) Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater (CTCAEv4.0). 8) Patients with treatment-required ischemic heart disease or cardiac disease such as arrhythmia (left ventricular hypertrophy associated with hypertension, mild left ventricular over-loading, or mild right bundle branch block etc. are acceptable for registration) 9) Patients with history of myocardial infarction within 6 months 10) Patients with liver cirrhosis 11) Patients with active bleeding at bowel with necessity for frequent transfusion 12) Patients with clinically serious psycho-neurological disease required for continuation therapy using psychotropic drug 13) Patients with uncontrollable diabetes 14) Patients with active double cancer 15) Patients with history of severe hypersensitivitie for other drugs 16) Patients required for continuous administration of phenytoin 17) Patients with obvious intraperitoneal inflammation 18) Patients with uncured surgical wound of serious operation 19) Patients with congenital hemorrhagic diathesis 20) Patients with administration of anticoagulant such as warfarin potassium 21) Patients with history of thromboembolism 22) Patients who are pregnant or breast feeding or possibility of pregnancy 23) Patients with severe comorbidity who are difficult for continuation of the protocol treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RECISTv1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy and safety. (1) Overall response duration, Complete response duration, Stable duration (2)Progression free survival (3)Time to treatment failure (4)Survival: Overall survival, OS, Median survival Time, 1-year survival, 2-year survival (5) Toxicity profiles, frequency, grade, timing Feasibility of novel and known biomarkers (1)Feasibility of novel biomarkers for prediction of response (2) Feasiblity of known biomarkers for prediction of efficacy or adverse effects (3) Establishment of new predictive markers, | — |
Countries
Japan
Contacts
Public ContactMasahiko Nishiyama
Saitama Medical University Frontier Medical Development Center
Outcome results
None listed