Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal cancer. 2)Clinically proven unresectable advanced/ metastatic colorectal cancer 3) 20 to 74 years of age 4) ECOG performance status 0-1 5) Presence of measurable lesion 6) No previous history of chemotherapy or radiotherapy for unresectable advanced/ metastatic colorectal cancer 8) Adequate organ functions 9) Estimated life expectancy 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1)Prior severe drug allergy. 2) Synchronous and/or metachronous multiple cancers. 3) Prior chemotherapy with CPT-11,L-OHP, capecitabeine or Bevacizumab containing regimen. 4)Surgical procedure within 28 days prior to enrollment. 5) Severe comorbidity - Severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - Severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 6) Sensory neuropathy 7) Severe diarrhea 8) Active infection 9) Symptomatic pleural effusion or ascites 10)Contraindications to CPT-11, L-OHP, capecitabeine or Bevacizumab 11) Concerning pregnancy 12) The investigator considers not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)