Phase I/II Trial of Bevacizumab in Combination With FOLFOXIRI As First-Line Therapy in Colorectal Cancer Patients With Liver Metastases

UMIN ID: UMIN000005413

Registered date:08/04/2011

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer patients with fore or more liver metastases
• Date of first enrollment: 2008/12/01
• Target sample size: 23
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment is administered every 2 weeks until evidence of DLT, progression, unacceptable toxicity, patient refusal, or for a maximum of 2 cycles to assess the feasibility. (phase I) Treatment is administered every 2 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for a maximum of 6 cycles to assess the rate of resection of liver metastases achieved after treatment with 6 cycles. (phase II)

Outcome(s)

• Primary Outcome: RD (phase I) Resection rate of liver metastases (phase II)
• Secondary Outcome: safety, the rate of R0 resection of liver metastases, overall response rate, TTF, PFS, RFS, OS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude criteria: 1. Clinical or radiological evidence of CNS metastases. 2. Current or previous (within the last 1 year) history of cerebrovascular disease 3. Major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days 4. Non-healing fracture 5. Current or previous (within the last 1 year) history of GI perforation 6. Non-healing ulcer 7. Bleeding diathesis or coagulopathy. 8. Current or recent (within 10 days ) treatment with anticoagulants for therapeutic purposes 9. Ongoing treatment with aspirin 10. Clinically significant (i.e. active) cardiovascular disease, or past or current history of myocardial infarction 11. Uncontrolled hypertension 12. Serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13. Uncontrolled pleural and/or peritoneal effusion 14. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:- Basal and squamous cell carcinoma of the skin, - In-situ carcinoma of the cervix 15. Interstitial lung disease, or pulmonary fibrosis 16. Uncontrolled infection 17. History of organ transplantation 18. Neuropathy >= Grade 1 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19. Diarrhea >= Grade 2 20. Pregnancy (positive serum pregnancy test) and lactation 21. Serious drug hypersensitivity or a history of drug allergy 22. History of adverse events related to fluorouracil 23. Participation in another investigational study within 4 weeks prior to enrollment 24. Bevacizumab, oxaliplatin and/or irinotecan used previous chemotherapy, fluorouracil based adjuvant chemotherapy within 6 months prior to enrollment 25. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Related Information

• Primary Sponsor: Yokohama City University School of Medicine
• Source(s) of Monetary Support: Yokohama City University School of Medicine