Metastatic colorectal cancer
Conditions
Interventions
FOLFOXIRI plus ramucirumab
Sponsors
Pharma Valley Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed adenocarcinoma of colon or rectum (excluding vermiform appendix and proctos) 2. Not resectable metastatic colorectal cancer 3. Age 20-75 at study entry 4. ECOG PS of 0 or 1 at study entry (PS of 0 if age 71-75) 5. Measurable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. No prior chemotherapy for advanced disease (previous adjuvant therapy by fluoropyrimidine monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant therapy and first relapse) 7. Adequate organ function 8. UGT1A1 genotype tested. Categorized into Wild (*1/*1) or single Hetero (*1/*28, *1/*6) 9. Written informed consent obtained prior to any study specific procedures
Exclusion criteria
Exclusion criteria: 1. Serious complications (e.g. other active co-existing malignancies, brain metastases, and malignant coelomic fluid required drainage) 2. Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks. 3. Grade >=2 peripheral neuropathy 4. Administration of blood transfusion or G-CSF within 2 weeks 5. Thromboembolism (grade 3 or higher) within 6 months 6. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity in the first cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, progression-free survival (PFS), PFS2, time to treatment failure, overall survival, and safety | — |
Countries
Japan
Contacts
Public ContactYosuke Kito
Shizuoka Cancer Center Division of Gastrointestinal Oncology
Outcome results
None listed