Colorectal cancer: KRAS wild type
Conditions
Interventions
Cetuximab: Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..) TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously
Sponsors
Kyushu Medical Oncology Group
Department of Medical Oncology, First Department of Internal Medicine, Faculty of Medicine, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colorectal cancer 2) KRAS WT unresectable advanced/recurrent colorectal cancer 3) Confirmed UGT1A1 genotype: both *6 and *28 wild type, or either *6 or *28 heterozygote type 4) Presence of measurable lesion 5) Age >=20 and =<75 6) Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1 7) Patients who had documented progressive disease after a minimum of 4 weeks of oxaliplatin and fluoropyrimidine containing chemotherapy. 8) No prior chemotherapy involving TS-1 or CPT-11 or Cetuximab. 9) Previous chemotherapy completed at least 2 weeks before inclusion. 10) Ability of oral intake 11) Submission of the available microsection (5-10um, more than 3 cut slides) to perform genetic test for KRAS and BRAF and microscopic test with hematoxylin-eosin stain. 12) With normal function of the important organs 13) Life expectancy of more than 3 months 14) With a written informed consent 15) Adequate organ function, evidenced by the following laboratory results within 1 week prior to registration. 1. WBC 3,000/mm3-12,000/mm3 2. Neurtophils >=1,500/mm3 3. Platelets >=100,000/mm3 4. Hemoglobin >=9.0g/dl 5. AST and ALT <=100IU/l 6. Total bilirubin <=1.5mg/dl 7. Creatinine <1.5mg/dl
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Phase I study To determine the maximum tolerated dose (MTD) and recommended dose (RD) 2) Phase II study Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactA. Makiyama
JCHO Kyushu Hospital Department of Hematology/Oncology
Outcome results
None listed