Patients with metastatic colorectal cancer
Conditions
Interventions
Patients receive FOLFOXIRI plus bevacizumab [L-OHP: 85 mg/sq.m., CPT-11: 165 mg/sq.m., 5-FU(c.i.v.): 3,200 mg/sq.m., l-LV: 200 mg/sq.m., bevacizumab: 5 mg/kg]. The treatment will be repeated every 2 w
Sponsors
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon or rectum. 2. Unresectable or recurrent colorectal cancer patient. 3. One or more measurable lesion in RECIST ver.1.1 criteria. 4. No prior chemotherapy, immunotherapy, and radiotherapy. 5. Life expectancy at least 3 months. 6. Patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28. 7. ECOG performance status of =<1. 8. Vital organ functions (listed below) are preserved within 14 days prior to entry. WBC: >= 3,000 per cubic millimeter Neu: >= 1,500 per cubic millimeter PLT: >= 100,000 per cubic millimeter AST and ALT: <= 100 IU/L , <= 150 IU/L in cases with liver metastasis T-bil: <= 2.0 mg/dL Serum creatinine: <= 1.50 mg/dL Proteinuria: <= 1+ PT-INR: < 1.5 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Vermiform appendix cancer and proctos cancer. 2. Administration of blood products/ G-CSF, and blood transfusion within 14 days. 3. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 4. HBs-Ag(+), or HCV-Ab(+). 5. History of severe allergy. 6. Sensory alteration or paresthesia interfering with function. 7. Prior radiotherapy for ilium and abdomen. 8. Infectious disease. 9. Uncontrolled diarrhea. 10. Ileus or bowel obstruction. 11. Interstitial lung disease or pulmonary fibrosis. 12. Malignant coelomic fluid required drainage. 13. Administration of atazanavir sulfate. 14. Heart disease to be clinically problem. 15. Major surgical procedure or intestinal resection within 28 days prior to enrollment or colostomy within 14 days prior to enrollment. 16. Known brain metastasis or strongly suspected of brain metastasis. 17. History of a thromboembolic disease. 18. Receiving anti-platelet drugs. 19. Poorly controlled gastrointestinal ulcer. 20. History of intestinal perforation within 12 months. 21. Poorly controlled hypertension. 22. Poorly controlled diabetes mellitus. 23. Severe mental disorders. 24. Women's pregnant or nursing, men/women who want to give birth or no intention to contraception. 25. Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure Progression-free survival Overall survival R0 resection rate Relative dose intensity Incidence of adverse events Early tumor shrinkage Deepness of response | — |
Countries
Japan
Contacts
Public ContactMasami Yamauchi
Hiroshima Prefectural Hospital Division of Clinical Oncology
Outcome results
None listed