Colorectal cancer
Conditions
Interventions
Phase I: IRIS + cetuximab S-1 80-120mg day1-14 Irinotecan 120-150mg/m2 day1 Cetuximab 250mg/m2 day1,8,15 (initial dose:400mg/m2) administered every 3 weeks until PD Phase
Sponsors
Kyushu Study group of Clinical Cancer(KSCC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Diagnosis of histologically confirmed metastatic adenocarcinoma of the colon or rectum (not anal canal cancer) 3) Inoperable, and no previous systemic chemotherapy 4) RAS mutation analysis 5) Unidimensionally measurable disease (RECIST ver.1.1 criteria) in truncal site (between chest and pelvis) by contrast enhanced CT. Baseline CT scan must be performed within 28 days prior to registration. 6) ECOG performance status of 0 or 1 7) Between 20-75 of age at informed consent (Phase I) >=20 years of age at study informed consent (Phase II) 8) Life expectancy of at least 3 months 9) Oral intake possible 10) Baseline laboratory tests within 14 days prior to registration.: i) Neutrophils >= 1,500/mm3 ii) Platelet count >= 100,000/mm3 iii) Hemoglobin >= 9 g/dL iv) Total bilirubin <= 1.5 mg/dL v) AST <= 100 IU/L (<= 200 IU/L in case of liver metastasis) vi) ALT <= 100 IU/L (<= 200 IU/L in case of liver metastasis) vii) Creatinine clearance >= 60 mL/min 11) UGT1A1 genotype tested: *6*28 wild (G/G), or *6*28 hetero (G/A)
Exclusion criteria
Exclusion criteria: 1) History of severe hypersensitivity reaction to any drugs 2) Synchronous or metachronous double cancer other in the last 5 years except early stage cancers which can be treated with a local treatment. 3) Symptomatic peripheral neuropathy >= grade 1 4) Severe dysesthesia or paresthesia with functional disorder 5) Diarrhea >= grade 2 6) Clinically relevant infectious diseases (active infection with body temperature; higher or equal to 38 degree) 7) Clinically relevant psychiatric or neurological condition including dementia which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication 8) Symptomatic brain metastasis 9) Severe complicating disorders (e.g. diabetes that is poorly controlled, uncontrolled high blood pressure, hepatic cirrhosis, hepatic failure, renal failure, interstitial pneumonia, pulmonary fibrosis, intestinal paralysis, ileus, cardiac disease) 10) Treatment with a blood product or hematopoietic growth factors (e.g. G-CSF) within 14 days prior to registration 11) Requiring treatment for ascites or pleural effusion 12) Congenital bleeding disorders or blood coagulopathy 13) Requiring ongoing treatment with a contraindicated concomitant medication (e.g. flucytosine, or phenytoin, warfarin potassium) 14) Previous radiotherapy for the primary lesion or any metastasis 15) Concurrent chronic systemic steroid treatment 16) Known history of hypersensitivity reaction to irinotecan 17) Previous exposure to cetuximab, irinotecan or S-1 therapy 18) Ongoing treatment with atazanavir sulphate 19) Hepatitis B surface antigen (HBsAg) or hepatitis-C virus (HCV) antibody positive 20) Any geographic or social circumstances or psychological or medical disorder, which, in the investigator's opinion, does not allow the patient to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: maximum tolerated dose (MTD) and recommended dose (RD) Phase II: objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: safety profile (incidence of adverse events and the severity) Phase II: overall survival, progression-free survivial, and the safety profile (incidence of adverse events and the severity) | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed