Colorectal cancer
Conditions
Interventions
Patients receive FOLFIRI with bevacizumab fixed 5mg/kg. (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.) Definision of UGT1A1 polymorphisms
Sponsors
Tokushima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer 2) Metastatic colorectal cancer 3) FOLFOX(+BV) or XELOX(+BV) treatment failure 4) Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms 5) Wash out:>=14 days for operation, and >=21 days for chemotherapy and/or radiotherapy 6) No prior irinotecan containing treatment 7) PS(ECOG):0 to 1 8) A life expectancy for at least 2 months 9) Aduquate main organ (bone marrow, heart, pulumonary, liver, renal) function WBC 3,000-12,000/mm3, Neutrophil >=1500/mm3 Platelet >=100,000/mm3 Hb >=8.5mg/dL AST(GOT) <=100IU/L ALT(GPT)<=100IU/L T-bilirubin <=2.0mg/dL serum creatinine <=1.50mg/dL 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of serious drug allergy 2)Active concomitant malignancy 3)Prior extensively irradiation for abdominal or bowel bone marrow 4)Symptomatic brain metastasis 5)Systemic continual use of steroids 6)Active infection 7)Persistent diarrhea (watery stool) 8)Intestinal obstraction or paralytic ileus 9)Interstitial pneumonia or pulmonary fibrosis 10)Massive pleural, pericardial effusion or asites that required drainage 11)Need to treatment with atazanavir sulfate 12)maintained phenytoin or warfarin 13)Uncontrolled diabetes mellitus 14)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment 15)Psychological disease deemed to unacceptable for inclusion to the study 16)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy 17)Other concominant medical condition deemed to inadequate for inclusion to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)incidence of adverse events 2)frequency of severe toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)response rate 2)time to treatment failure 3)progression free survival 4)overall survival | — |
Countries
Japan
Contacts
Public ContactMasanori Nishioka
The University of Tokushima Graduate School Department of Digestive and Pediatric Surgery
Outcome results
None listed