KRAS wild type metastatic colorectal cancer
Conditions
Interventions
Panitumumab with irinotecan/S-1(IRIS) S-1,80-120mg/body for twice daily 14 consecutive days followed by 2 weeks rest combined with intravenous CPT-11 100mg/m^2 and P-mab 6mg/kg(weight) given on day1,
Sponsors
Tohoku-Six Universities Research Group by Experts(T-SURGE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven colorectal cancer. 2. Unresectable advanced/recurrent colorectal cancer. 3. KRAS wild type. 4. Measurable lesions or evaluable lesions are confirmed by CT. 5. Metastatic and/or recurrent disease and no prior chemotherapies. 6. No prior chemotherapy involving L-OHP, CPT-11, Panitumumab or Cetuximab. 7. Age>=20 and life expectancy of more than 3 months. 8. Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1. 9. Patients who have adequate bone marrow and organ functions are preserved within 14 days prior to entry. (1)3,000/mm^3 <= WBC < 12,000/mm^3 (2)Neutrophils >= 1,500/mm^3 (3)Platelets >= 100,000/mm^3 (4)Hemoglobin >= 9.0g/dL (5)Total bilirubin <= 2.0mg/dL (6)AST(GOT) <= 100IU/L (7)ALT(GPT) <= 100IU/L (8)Creatinine < 1.5mg/dL (9)CCr:>=50mL/min Ccr(mL/min)= weight(kg)*(140-age)/72*Creatinine (mg/dL) However, woman multiply 0.85. If 50mL/min <= CCr < 80mL/min, start dose of S-1 is reduced one level down. 10. Capability of oral intake. 11. Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1. Patients who have allergy for drugs. 2. Patients who have other malignancies. 3. Infectuins in active. 4. Patients who have past histories of bowel perforation and/or bowel obstruction in one year before registration. 5. Serious complications (e.g.,interstitial pneumonitis, pulmonary fibrosis, heart failure, renal failure, hepatic failure or uncontrolled high blood pressure or diabetes mellitus). 6. Pleural effusion and/or ascites to need treatment. 7. Watery diarrhea. 8. Patients who have given a dose of flucytosine or atazanavir sulfate. 9. Patients who have brain metastases. 10. Pregnant woman, nursing mothers, possibly pregnant woman and wishing to become pregnant. 11. Patients who have severe mental disease. 12. The Patient that a study responsibility physician judged to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Disease control rate, Time to treatment failure, Duration of response, Resection rate of metastases, Adverse events | — |
Countries
Japan
Contacts
Public ContactMotoi Koyama
Hirosaki University Graduate school of Medicine Dept. of Gastroenterological Surgery
Outcome results
None listed