advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Conditions
Interventions
<
Administration schedule>
One couese takes 28 days. TS-1:TS-1(14days),interval(14days) CPT-11:Day1,Day15,Day29 Cetuximab:Day1,Day8,Day15,Day22,Day29 TS-1:80mg/m2 CPT-11:100mg/m2 Cetuximab:only one couse (400mg/m2)
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colon cancer or rectal cancer 2) genetically proven KRAS wild type of the tumor tissue 3) with measurable lesions for RECIST criteria 4) Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment and without treatments including CPT-11 and/or Cetuximab 5) patients older than 20 years 6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less. 7) A predicted life expectancy of at least 3 months. 8) with prior chemotherapy completed before more than 20 days 9) with normal function of the important organs 10) Ability of oral intake 11) Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) with treatments including CPT-11 and/or Cetuximab 2) with active double cancers 3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 4) Infectious disease 5) Diarrhea (watery stools) 6) with obstruction or disorder on digestive tract due to peritoneal metastasis 7) with ascites and/or pleural fluid 8) History of serious drug hypersensitivity 9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate. 10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion. 11) With liver cirrhosis or jaundice. 12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment. 13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment. 14) With diabetes that is difficult to control. 15) With central nervous system metastasis 16) women pregnant, breast-feeding, or who wish pregnancy 17) Any other patient whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate(RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)survival time 2)Time to progression 3)Ratio controling the tumor 4)Adverse events 5)Incidence of skin illness in grade 2-3 | — |
Countries
Japan
Outcome results
None listed