NIPH Clinical Trials Search

UMIN ID: UMIN000001127

Registered date:01/06/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUnresectable advanced/recurrent colorectal cancer
Date of first enrollment2008/06/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1-6 Course Bevacizumab+mFOLFOX6 7-18 Course Bevacizumab+sLV5FU2 19- Course Bevacizumab+mFOLFOX6


Primary OutcomeDuration of disease control
Secondary OutcomeSafety Reintroduction rate Overall response rate Overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum74years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name TCOG Gastric Cancer affairs office
Address Toa-Bldg. 4F 2-1-18 Hamamatsu-cho Minato-ku Tokyo Japan Japan
Telephone 03-5401-5020
Affiliation The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency
scientific contact
Name Atsushi Sato
Address 5 Zaifu-cho Hirosaki-city Aomori Japan Japan
Telephone 0172-39-5346
Affiliation Hirosaki University Graduate School of Medicine Department of Medical Oncology