metastatic colorectal cancer
Conditions
Interventions
Panitumumab
tri-weekly administration 9mg/kg. and CPT-11 is administered as an intravenous infusion at a dose of 150mg/m2(or 125 mg/m2)on day 1 and TS-1 is orally administered on days 1-14 of a 21-day cycle. Admi
Sponsors
Fukuoka Tumor Research(FUTURE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal cancer 2)Histologically confirmed KRAS wild type on the tumor tissue 3)Unresectable advanced or metastatic colorectal cancer 4) patients with tumor resistant/intolerant to oxaliplatin,fluoropyrimidine 5) ECOG performance status 0,1 6) Age between 20 to 80 years 7) Written informed consent 8) with a good condition of important organs 1.Hb >=9.0g/dl 2.WBC>= 3,000/mm3, <=12,000 mm3 3.neutrophil >= 1,500/mm3 4.platelet >= 100,000/mm3 5.Creatinine < 1.5mg/dl 6.Creatinine clealance: >=50mL/min 7.ALT/AST <= 100IU/l (200 IU/l if the patients has liver metastasis) 8.total bilirubin <= 1.5mg/dl 9)Oral administration of S-1 is possible. 10)Life expectancy of more than 3 months. 11)Presence of measurable lesion 12)Periods from prior treatment have elapsed more than two weeks 13)Prior radiotherapy is not acceptable
Exclusion criteria
Exclusion criteria: 1)Patients with severe complications,(severe cardiovascular disease,severe heart disease,heart failure,liver failure,renal failure or uncontrollable diabetes mellitus) 2)Patients with active infection 3)Patients with severe interstitial pneumonitis or pulmonary fibrosis 4)Patients with active double cancer 5)Patients with paralytic ileus, bowel obstruction 6)Patients with uncontrollable ascites and pleural effusion 7)Patients with diarrhea 8)Patients with the past history of severe allergic reactions 9)Patient with regular use of furucytocin or fenytoin,warfarin 10)psychiatric patients 11)pregnant or nursing patient or with intent to bear baby 12)Patients with the past history of treatment of S-1 and CPT-11 and Panitumumab, Cetuximab 13)Patients with regular use of steroids(oral or intravenous) 14)Patients with brain metastasis 15)Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phase1 recommend dose of 1st cycle phase2 response rate | — |
Countries
Japan
Contacts
Public ContactYoichiro Yoshida
Fukuoka University School of medicine Department of Gastroenterologial Surgery
Outcome results
None listed