Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer

UMIN ID: UMIN000002042

Registered date:05/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced colorectal cancer
• Date of first enrollment: 2009/06/01
• Target sample size: 65
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is followed by 6 cycles of bi-weekly sLV5FU2 plus bevacizumab regimen. Agter the 12 cycle treatment, 6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is re-administred. Or 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is followed by 4 cycles of Trii-weekly Capacitabine plus bevacizumab regimen. After the 8 cycle treatment, 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is re-administred.

Outcome(s)

• Primary Outcome: median prpgression free survival (PFS)
• Secondary Outcome: response rate (RR), overall survival (OS), time to treatment failure (TTF), and incidence of neurotoxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria: 1. patient treated with blood transfusion, blood products or G-CSF within 7 days before registration. 2.patient who has or clinically suspicious for brain metastasis. 3. patient with a mental disorder or a history of a CNS disorder 4. patient with paresthesia 5. patient who need drainage of peritoneal, pleural or pericardial effusion. 6. double cancer 7. hypercalcemia (albumin-modified Ca value 12mg/dl or more). 8. poorly controlled diabetes mellitus. 9. proteinuria (grade 2 or more) 10. history of severe drug hypersensitivity or drug allergy 11. poorly controlled hypertension 12. obvious abnormality in ECG

Related Information

• Primary Sponsor: Tohoku Clinical oncology, reserach and Education Society (T-CORE)
• Source(s) of Monetary Support: Tohoku Clinical oncology, reserach and Education Society (T-CORE)