Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer

Phase 2

• Conditions: Patients with metastatic colorectal cancer

• Registration Number: JPRN-UMIN000017102
• Lead Sponsor: Translational Research Informatics Center, Foundation for Biomedical Research and Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-19
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
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