Phase I/II study of Cetuximab combined with S-1 and irrinotecan (CeIRIS) in KRAS wild type metastatic colorectal cancer patients refractory to treatment with oxaliplatin and fluoropyrimidine.
- Conditions
- Colorectal cancer: KRAS wild type
- Registration Number
- JPRN-UMIN000003288
- Lead Sponsor
- Kyushu Medical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Severe comorbidity (active infectious disease, severe cerebrovascular disorder, uncontrolable diabetes, heart failure, angina, myocardial infarction within three months, severe hepatic disorder, jaundice etc) 2) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 3) Massive pleural effusion or ascites 4) Symptomatic brain metastasis 5) Wattery diarrhea 6) Paralytic or mechanical bowel obstruction 7) Patients who is receiving Fluorocytosine 8) Patients who is receiving Atazanavir Sulfate 9) Simultaneous or metachronous double cancers 10) History of severe allergy 11) Current chronic daily treatment with corticosteroids(oral intake or intravenously) 12) Severe infectious disease 13) Amalgamation of mental disease or psychotic manifestation 14) Pregnant or lactating women or women of childbearing potential. 15) Any other patient whom the physician in charge of the study judges to be unsuitable.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Phase I study To determine the maximum tolerated dose (MTD) and recommended dose (RD) 2) Phase II study Response rate
- Secondary Outcome Measures
Name Time Method 1) Phase I study To evaluate the toxicity and efficacy 2) Phase II study Progression-free survival, Overall survival, Disease control rate, Time to treatment failure and Safety profile