Colorectal cancer
Conditions
Interventions
Bevacizumab and irrinotecan based chemotherapy (q2w FOLFIRI, q3w XELIRI, q3w/q4w IRIS)
Sponsors
SGCSG: Shimane Gastroenterological Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Disease progression(PD) or difficult to continue for other reason after chemotherapy with bevacizumab as 1st line Oxaliplatin containing regimen (with measurable lesions in RECIST criteria) (2) Oxaliplatin and bevacizumab were administrated for more than 4 times in 1stline (3) Colorectal cancer, cytologically and/or histrogically (4) Written informed consents (5) Age: 20 years old and above (6) Performance Status(ECOG):0~1 (7) Life expectancy estimated >= 3 months (8) Sufficient organ functions
Exclusion criteria
Exclusion criteria: (1) Previously irinotecan treatment (2) Administering transfusion/ hematopoietic factor or antithrombotic drug within 14 days (3) Serious renal dysfunction (4) Serious drug hypersensitivity or a history of drug allergy (5) Active concomitant malignancy (6) Active infections (7) Symptomatic or asymptomatic but treated heart disease (8) History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema (9) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer (10) Pleural effusion, peritoneal fluid and pericardial fluid (11) Symptomatic brain metastasis (12) History of mental disturbances or cerebrovascular accident (13) High blood pressure and diabetic that cannot be controlled (14) Uncontrolled diarrhea (15) Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study (16) Traumatic fracture of unrecovery (17) Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) (18) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers (19) Need to treatment with atazanavir sulfate (20) Paralyzed bowel (21) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, Treatment to failure, Overall survival, Safety, Analysis by age, regimen and UGT1A1 | — |
Countries
Japan
Outcome results
None listed