Colorectal Cancer
Conditions
Interventions
CXCR4-CEC>
=20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2
CXCR4-CEC>
=20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2
CXCR4-CEC<
20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2
CXCR4-CEC<
20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2
Sponsors
The Cancer Institute Hospital of JFCR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proved Colon cancer or rectalcancer 2) KRAS wild-type 3) measurable lesion 4) Age:20 to 80years 5) ECOG performance status of 0, 1 or 2 6) Expected survival >=3 months 7)Signed informed consent of the patient for registration 8) Adequate organ functions as listed below (at <=14 days prior to enrollment) WBC:4,000/mm3 to 12,000/mm3 Neutrophl: 2,000/mm3 to 6,000/mm3 Plt: >=100,000/mm3 Hb: >=9.0g/dL Total bilirubin <= upper limit of normal (ULN)*1.5 AST ,ALT and ALP <= upper limit of normal (ULN)*2.5 Serum creatinine <=upper limit of normal (ULN)*1.5
Exclusion criteria
Exclusion criteria: 1)Prior severe drug allergy 2) Be Administered or less than 7 days finished administration Compound Drug of tegafur,gimeracil and oteracil potassium 3) The anti-EGFR antibody (Panitumumab or Cetuximab) has been prescribed for the patient until now. 4) A patient with myelosuppression 5) Patients with large quantity of pleural effusion or ascites 6) Active infection 7) A patient with intestinal tract paralysis and ileus 8) A patient with jaundice 9) A patient with a critical renal damage or a liver damage 10) Under Flucytosine medication 11) severe pulmonary dysfunction 12)K-RAS mutation 13) Concerning pregnancy 14) Complication of cerebrovascular disease or symptoms within 1 years 15) Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week 16) Administering antithrombotic drug within 10 days 17) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS 18) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor as INR>=1.5 19) active peptic ulcer 20) History of gastrointestinal perforation within 1 year 21) Traumatic fracture of unrecovery 22) Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination 23) Uncontrollable hypertension 24) Uncontrollable diabetes mellitus 25) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial 26) History of hypersensitivity against fluorouracil or platinum agents. 27) History of organ transplantation 28)any other cases who are regarded as unsuitable for enrollment in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile, Overall survival, Time-to-treatment-failure , Overall Response Rate | — |
Countries
Japan
Contacts
Public ContactSatoshi Matsusaka
The Cancer Institute Hospital of JFCR Department of Gastroenterology
Outcome results
None listed