Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer

UMIN ID: UMIN000000883

Registered date:08/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 5FU Leucovorin Irinotecan Oxaliplatin

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Severe infection 2. 3. History of Irinotecan, and Oxaliplatin use 4. Severe complication 5. 6. Regular use of 7. History of thromboembolism 8. Unmanageable hyper tention 9. Active ulcer 10. Symptomatic brain metastasis 11. 12. 13. 14. History of radiotherapy 15. Massive pleural effusion required drainage 16. Persistent diarrhea 17. 18. 19. HBs antigen and HCV antigen positive 20. Pregnancy or the desire to preserve fecundity 21. 22. Psychological disease deemed to unacceptable for inclusion to the study 23. 24. Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center
• Source(s) of Monetary Support: Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center