Neo Ras Wild type metastatic colorectal cancer
Conditions
Interventions
Combination therapy of panitumumab plus irinotecan: Patients receive panitumumab (intravenous dose of 6 mg/kg) plus intraveous infusion of irinotecan of 150 mg/m2 (body surface area). Treatment cycles
Sponsors
Shinozaki Eiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: 1) Must give written Informed Consent 2) Histologically proven diagnosis of colorectal adenocarcinoma 3) Advanced or recurrent colorectal cancer (excluding appendix and anal canal cancer) 4) Age>= 20 years 5) Eastern Cooperative Oncology Group (ECOG) performance status = 1500/ mm3 b.Platelets >= 75000/mm3 c.Serum total bilirubin <= 1.5 mg/dL d.Serum AST(GOT) and ALT(GPT) <= 100 U/L(except for patients with tumor involvement of the liver who must have AST and ALT <= 200 U/L) e.Serum creatinine <= 1.5 mg/dL
Exclusion criteria
Exclusion criteria: Patients eligible for inclusion in this study must not meet any of the following criteria: 1) Evidence of BRAF V600E MT by tumor histology. 2) Treated with blood transfusion, blood products, or hematopoietic factor products such as Granulocyte Colony Stimulating Factor within 7 days prior to enrollment in this study. 3) Have a history of severe drug hypersensitivity or severe drug allergy 4) Active infection (fever of 38 degree or higher due to infection). 5) Ascites, pleural effusion, or pericardial effusion requiring continuous drainage. 6) Uncontrolled diabetes mellitus. 7) Uncontrolled hypertension. 8) Patients who have been treated with any of the following treatments prior to starting study drug: a.Extensive surgery <= 4 weeks prior to starting study drug (e.g., surgical treatment with organ resection, excluding colostomy) b.Proctocolectomy <= 2 weeks prior to starting study drug c.Any chemotherapy <= 2 weeks prior to starting study drug d.Radiotherapy <= 2 weeks prior to starting study drug 9) Clinically significant electrocardiographic abnormality or clinically significant cardiovascular accidents within 6 months prior to study enrollment, including myocardial infarction, severe unstable angina, or New York Heart Association functional classification class III or IV congestive heart failure. 10) Patients with severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema). 11) History of clinically significant mental disorder or central nervous system disorder. 12) Symptomatic brain metastasis or clinically suspected brain metastasis upon symptoms. 13) Diarrhea that interferes with daily life. 14) Intestinal paralysis, intestinal obstruction. 15) Co-existing active malignancies. 16) Pregnant or lactating women; women of childbearing potential or men with women partners of childbearing potential who are unwilling to use a highly effective method of contraception or avoid intercourse during and upon completion of the study. 17) Patients who are judged by the site physician to be inappropriate for this study. 18) Patients who have been treated with EGFR inhibitors prior to starting study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Disease control rate, Adverse event | — |
Contacts
Public ContactHiroki Osumi
The Cancer Institute Hospital of JFCR
Outcome results
None listed