Phase II study of Bevacizumab plus modified OPTIMOX1 in patients with unresectable advanced/recurrent colorectal cancer

UMIN ID: UMIN000001127

Registered date:01/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable advanced/recurrent colorectal cancer
• Date of first enrollment: 2008/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1-6 Course Bevacizumab+mFOLFOX6 7-18 Course Bevacizumab+sLV5FU2 19- Course Bevacizumab+mFOLFOX6

Outcome(s)

• Primary Outcome: Duration of disease control
• Secondary Outcome: Safety Reintroduction rate Overall response rate Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude criteria: 1. Pleural effusion,peritoneal fluid,and pericardial fluid 2. Symptomatic brain metastasis 3. Active concomitant malignancy 4.With Neurological disorder of brain blood vessel 5. Any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier)or aspiration biopsy within one week 6. Administering antithrombotic drug to the thrombus syndrome within seven days 7. Anti-platelets therapy(including aspirin and NSAIDS) 8. Bleeding tendency,coagulation abnormality 9. Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and uncontrolled peptic ulcer 10 current or previous (within one year) history of GI perforation 11. Traumatic fracture of unrecovery 12. Renal damage that requires treatment 13. High blood pressure and diabetic that cannot be controlled 14. Symptomatic or asymptomatic but treated heart disease 15. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium 16. Interstitial pneumonitis, pulmonary fibrosis 17. Peripheral neuropathy of grade 1(CTCAE v.3.0) or more 18. Infectious disease that cannot be controlled 19. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 20. Man who doesn't have intention to which it practices birth control 21. Other conditions not suitable for this study

Related Information

• Primary Sponsor: The Tokyo Cooperative Oncology Group
• Source(s) of Monetary Support: The Tokyo Cooperative Oncology Group