Cetuximab plus S-1 and irinotecan (IRIS) as first-line treatment in RAS wild type metastatic colorectal cancer, a phase I/II trial (KSCC1401)

Phase 1

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000015835
• Lead Sponsor: Kyushu Study group of Clinical Cancer(KSCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I: maximum tolerated dose (MTD) and recommended dose (RD) Phase II: objective response rate

Secondary Outcome Measures

Name	Time	Method
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)