KRAS wild-type metastatic colon cancer.
Conditions
Interventions
We use three drugs (CPT-11, S-1, Panitumumab) for this trial. The treatment schedule of CPT-11 and Panitumumab are administrated on day 1 and day 15, and of S-1 is administrated between day1 and day 2
Sponsors
Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The eligibility criteria were as follows: 1)2)3) histologically proven unresectable metastatic colorectal adenocarcinoma with assessable lesions; 4) previous first line chemotherapy containing oxaliplatine, and was progression disease or treatment failure; 5) KRAS wild-type 6) at least 2 weeks must have elapsed since any prior chemotherapy; 7) prior radiation therapy are not done; 8) age 20-80 years patients; 9) Eastern Cooperative Oncology performance status (PS) 0-1; 10) survival period more than 3 months; 11) adequate organ function before fourteen days, defined as leukocyte count >4000-12000/mm3, platelet count >100000/mm3, neutrophil cell count >2000/mm3, hemoglobin >9.0 g/dl, serum transaminase (aspartate aminotransferase and alanine aminotransferase) <100/UI (in case of hepatic metastatic patients are at a physician's discretion), serum bilirubin level <1.5mg/dl, serum creatinine level <1.2mg/dl, estimated creatinine clearance level > 50ml/min (in case of woman, the value is 0.85 times); 9) the patients who can take oral drugs; 10) patients determined by electrocardiography within 28 days before entry, and allowed to enroll this trial by primary doctor; 12) and written informed consent from the patients; 13) the patients can eat This study was approved by the ethics committees in each institution.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows; patients were not eligible for this study if; 1) they had undergone treatment with CPT-11 chemotherapy prior to this study, 2) had active double cancer; 3) had active infection disease (over 38.0C fever); 4) had gastrointestinal paralysis, bowel blockage or history within 1 year before entry; 5) had serious interstitial lung disease and lung fibrosis; 6) had water solubility diarrhea; 7) had diabetes mellitus which could not be controlled; 8) had hypertension which could not control with drug therapy; 9) had proteinuria > 2 plus 10) had serious complication (e.g. heart failure, hepatic failure, kidney failure); 11) had comorbid disease of cerebral vascular disorder or history within 1 year before entry; 12) were operated or performed dissected biopsy within 4 weeks before entry; 13) were bleeding tendency, coagulation disorder, abnormality of coagulation factor (INR>1.5) within 2 weeks before entry; 14) were administered antithrombotic within 10 days before entry; 15) were administered antiplatelet agent for chronic rheumatoid arthritis; 16) were administred flucytosine or atazanavir ; 17) were systemically-administered of steroids ; 18) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant ; 19) had a previous serious medical illness or allergy for drugs ; 20) had brain metastasis or had treated for brain metastasis ; 21) had myelosuppression ; 22) had pleural effusion or abdominal dropsy which need therapy ; 23) had jaundice ; 24) except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Overall survial Time to Treatment Failure Safety | — |
Countries
Japan
Contacts
Public ContactYasumasa Takii
Niigata Cancer Center Hospital Department of Surgery
Outcome results
None listed