colonrectal cancer
Conditions
Interventions
Irinotecan (100 mg/m2) and panitumumab (6 mg/kg) on days 1 and 15 and S-1 (40&
60 mg according to body surface area) twice daily for 2 weeks, repeated every 4 weeks.
Sponsors
The University of Tokushima Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven KRAS wild type colorectal adenocarcinoma 2) with measurable lesions for RECIST criteria 3) patients with tumor resistant/intolerant to irinotecan or recurrence within 6 months after the adjuvant therapy 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1,or 2. 5)No past history of severe interstitial pneumonitis, pulmonary fibrosis 6) with a good condition of important organs a.Hb >=9.0g/dl b.WBC>= 3,000/mm3, <=12,000 mm3 c.neutrophil >= 1,500/mm3 d.platelet >= 100,000/mm3 e.total bilirubin <= 1.5mg/dl f.ALT/AST <= 2.5 times of normal limit g.creatinine <= 1.2mg/dl
Exclusion criteria
Exclusion criteria: 1)Patients with the past history of severe allergic reactions 2)Patients with the past history of treatment of irinotecan and panitumumab 3) Patient with active double cancer 4)Patient with active infection 5) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6)Patients with severe interstitial pneumonitis or pulmonary fibrosis 7)Patients with uncontrollable ascites and pleural effusion 8)Patients with diarrhea 9) Patient with regular use of furucytocin or fenytoin 10)Patients with symptomatic brain metastasis 11) pregnant or nursing patient or with intent to bear baby 12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Overall survival Progression free survival Adverse events | — |
Countries
Japan
Outcome results
None listed