Colorectal Cancer
Conditions
Interventions
Cetuximab 500 mg/m2/every 2weeks (day1) CPT-11 100 or 150 mg/m2 every 2weeks (day1) l-LV 200 mg/m2/every 2weeks (day1) 5-FU/bolus 400 mg/m2/every 2weeks bolus (day1) 5-FU/infusional 2,400 mg/m2/
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histolopathologically confirmed colorectal cancer (2) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed. (3) The case that presence or absence of genetic polymorphism of UGT1A1 *6 and UGT1A1 *28 is confirmed in peripheral blood. (4) Unresectable metastatic and/or recurrent colorectal cancer. Prior Oxaliplatin adjuvant therapy is allowed if it is completed at least 24 weeks before registration. Excluded prior chemotherapy CPT-11 and/or EGFR antibody. (5) Age: 20-75 (6)ECOG performance status 0-2 (7)Presence of at least one measurable lesion (according to the RECIST ver1.1) (8)Patients have enough organ function for study treatment i) WBC: >=3,000/mm3 ii) ANC: >=1,500/mm3 iii) Plt: >=100,000/mm3 iv) Hb: >=8.0g/dL v) Total bilirubin<=upper limit of normal (ULN)*2 vi) AST(GOT) and ALT(GPT): <=100*IU/L (<=ULN*5 in case of liver metastasis) vii) Creatinine: <=1.5mg/dL (9)Life expectancy of more than 3 months (10)Written informed consent
Exclusion criteria
Exclusion criteria: (1)Severe bone marrow suppression (2)History of severe allergy (3) Active infection (include type B , C a hepatitis carrier) (4)Wattery diarrhea (5)Paralytic or mechanical bowel obstruction (6)Massive pleural effusion or ascites (7)Severe heart failure (8) Uncontrolled DM (9)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (10)Jaundice (11) Multiple bone metastasis (12)Simultaneous or metachronous double cancers (Carcinoma in situ is eligible). (13)Patients who is receiving Atazanavir Sulfate (14) Mental disorder, central nervous system disorder or severe cerebrovasculara disease (15) Radiotherapy to target lesion (Adjuvant radiation therapy before and after the curative resection ) (16) Pregnant or lactating women or women of childbearing potential or men who are planning family (17)Severe complications (18)Symptomatic brain metastasis (19) Active bleeding or blood transfusion within two weeks. (20) Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, According to part response rate, Disease control rate, Safety profile, R0 resection rate, waterfall plot analysis, Cumulative response rate (30%), Effective reduction ratio (ROC), Cytoreductive ratio and duration for the liver | — |
Countries
Japan
Contacts
Public ContactNorisuke Nakayama
Kanagawa Cancer Center Gastroenterology
Outcome results
None listed