patients with advanced or recurrent colorectal cancer after failure or unfeasible L-OHP+5-FU regimen
Conditions
Interventions
Treatment by IRIS+Rmab Ramucirumab at a dose of 10mg/kg was administered as a 120-min infusion and irinotecan at a dose of 150mg/m2 by adjustment by UGT1A1 was administered as a 90-min infusion ev
s body surface area (BSA). Specifically, the drug was administered orally twice daily for 14 consecutive days at a dose that did not exceed 40 mg/m2 based on BSA as follows-BSA<
1.25m2, 40 mg
BSA 1.25-1.5 m2, 50mg twice daily
and BSA >
1.5 m2, 60 mg by adjustment of Ccr. Premedication with a 5-HT3 antagonist combined with dexamethasone (+/-) an NK-1 antagonist was recommended in patients before the administration of irinotecan. This
s decision to terminate treatment.
Sponsors
Nagasaki University Graduate School of Biomedical Sciences, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients enter in this study such that 1) acquisition of written informed consent 2) the case whom investigators recognize appropriate for joining this trial 3) having histologically confirmed advanced or metastatic colorectal cancer 4) withdrawal from first-line oxaliplatin-based chemotherapy because of intolerable toxicity or progressive disease or relapse within 180 days after the last oxaliplatin-based adjuvant chemotherapy 5) past history of radiation for target lesion except for palliative use (bone metastasis) 6) age > 20 years 7) Cooperative Oncology Group (ECOG) performance status of 0 or 1 8) having measurable lesion on the basis of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria ver 1.1 9) tolerate oral intake 10) adequate bone marrow, hepatic, and renal function that were satisfiied with the below 1) white blood cell count >3,000/mm3,< 12,000/mm3 2) ANC >3,000/mm3 3) platelet cell count >100,000/mm3 4) hemogulobin> 9.0g/dL 5) serum total bilirubin <1.5 UNL 6) AST< 2.5 UNL (in case of liver metastasis<5.0 UNL) 7) ALT< 2.5 UNL (in case of liver metastasis<5.0 UNL) 8) serum creatinine<1.5 UNL 9) urine protein: 0, +/-, 1+ or 2+ and Up/Uc<2.0 10) Ccr >= 30mL/min 11) UGT1A1 polymorphism: *6, *28 except for double homo 12) estimated life expectancy of >3 months
Exclusion criteria
Exclusion criteria: Patients are excluded from this study for any of the following reasons 1) severe complicationssuch as intestinal pneumonia, lung fibrosis, renal dysfunction, hepatic dysfunction, uncontrolled hypertension, severe diabetes mellitus requiring insulin 2) remarkably abnormal electrocardiogram, symptomtic heart disease (heart failure, myocardial infarction,angina) 3) symptomatic infectious disease, under or no treated HCV 4) symptomatic pleural effusion or ascites such as needing frequent puncture 5) past history of severe drug allergy 6) active double cancer 7) psychopathy, abnormal central nervous system, cerebrovascular disease 8) radiological evidence of brain tumor or brain metastases, 9) gastrointestinal ulcer, bleeding, obstruction, paralysis, perforation 10) obstructive bowel disease 11) watery diarrhea, or more than Grade2 diarrhea 12) past history of thrombosis or cerebral infarctinon except for asymptomatic lacunar infraction 13) congenital bleeding tendency, 14) need anti-coagulant drug except equivalent low-dose aspirin (<325mg) 15) need steroidal drug 16) need flucytosine or Atazanavir sulfuric acid 17) pregnancy, breast feeding 18) female patient hope for partner pregnancy 19) previous treatment with irinotecan hydrochloride 20) history of hemoptysis grade2, radiological 21) contraindication of S-1, CPT-11, ramucirumab 23) the case whom investigators recognize inappropriate for joining this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progrssion free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate over all survival (OS) safety (adverse events) quality of life (QOL) (1, 2 courses and end of trial) review of nausea and vomiting for 1 through 3 courses | — |
Countries
Japan
Contacts
Public ContactKazuma Kobayashi
Nagasaki University Graduate School of Biomedical Sciences Department of Surgery
Outcome results
None listed