KRAS or RAS wild-type metastatic colorectal cancer
Conditions
Interventions
FOLFOXIRI+Panitumumab (Until 12 courses) Panitumumab 6mg/kg/bi-weekly Irinotecan 165-125mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 3200mg/m2/bi-weekly
Sponsors
Nonprofit Organization Japan Clinical Cancer Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed colorectal cancer (Adenocarcinoma). (2) KRAS wild-type, or RAS wild-type. (3) Presence of evaluable lesion. (4) No prior chemotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors. (5) Age; more than 18 years old. (6) ECOG Performance status 0-1. (7) UGT1A1*6*28 wild type or single hetero. (8) Life expectancy of more than 3 months.(9) Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 2,000/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 10.0g/dL. 5) Total Bilirubin<= 1.5mg/dL. 6) AST<= 100IU/L. 7) ALT<= 100IU/L. 8) Creatinine<= 1.5mg/dL. (10) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (3) Brain metastases. (4) Active infection. (5) Serious complication (Interstitial pneumonia, Chronic obstructive pulmonary, Idiopathic pulmonary fibrosis, Renal failure, Hepatic failure, Uncontrolled Deabetes, Uncontrolled hypertention, Angina requiring treatment, Cardiac failure, Jaundice). (6) Ileus or bowel obstruction. (7) Large quantity of pleural, abdominal or cardiac effusion. (8) diarrhea. (9) peripheral neuropathy greater than Grade 2. (10) Active viral hepatitis. (11) Administration of atazanavir sulfate. (12) History of severe allergy. (13) History of organ recipient. (14) History of myocardial infarction, unstable angina within 3 months prior to the registration. (15) Prior Panitumumab/Irinotecan/Oxaliplatin treatment. (Adjuvant therapy by Oxaliplatin is excluded) (16) severe mental disorders. (17) Systemic steroid user. (18) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (19) Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion rate of the protocol treatment (Until 12 courses) Time to Treatment Failure Overall Survival Progression Free Survival Safety Response Rate | — |
Countries
Japan
Contacts
Public ContactMasashi Fujii
Nonprofit Organization Japan Clinical Cancer Research Organization Office
Outcome results
None listed