advanced and recurrent colorectal cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 i.v.(day1) Bevacizumab 7.5mg/kg i.v.(day1) Capecitabine 2000mg/m2 p.o.(day1-14) to be repeated every 3weeks
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven colorectal cancer (adenocarcinoma) 2)No prior treatment for advanced and recurrent colorectal cancer 3)With bevacizumab plus XELOX 4)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 5)Performance Status:0-1 (ECOG) 6)Written informed consent is taken 7)Required baseline laboratory parameters (within one week before registration) 1.neutrophils>=1,500/mm3 2.platelets>=100,000/mm3 3.hemoglobin>=9.0g/dL 4.T-Bil within 1.5 times of normal limit of each hospital 5.AST,ALT,ALP within 2.5 times of normal limit of each hospital(in case of hepatic metastatic patients are within 5.0 times of normal limit ) 6.Cre within 1.5 times of normal limit of each hospital 8)Creatinine clearance<=50ml/min
Exclusion criteria
Exclusion criteria: 1)Contraindication of bevacizumab oxaliplatin and capecitabine 2)Brain tumors or brain metastasis 3)Presence of cerebrovascular disease or symptoms less than 1 year prior to entry 4)Any surgical treatments oncluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 5)Non-healing bone fracture 6)Uncontrolled peptic ulcer 7)Uncontrolled hypertension 8)the internal organ transplant 9)Interstitial pneumonitis, pulmonary fibrosis 10)Uncontrolled Infection 11)Renal failure to be treated, 1+ or higher proteinuria within 1 weeks prior to entry 12)History of adverse events related to DPD loss 13)Daily treatment wit high-dose aspirin (>=325/day) or non-steroidal anti-inflammatory medications 14)Pregnant women, nursing mothers, possibly pregnant women 15)Perforation of gastrointestinal tract less than 1 year prior to entry 16)Clinically significant (i.e. active) cardiovascular disease (>= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 4), clinically important echocardiographic findigs, or past or current history (within the last 1 year) of myocardial infarction 17)Peripheral neuropathy of at least grade 1 18)Uncontrolled pleural and/or peritoneal effusion 19)Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Time to treatment-failure Liver resection rate Liver R0 resection rate Safety Efficacy according to K-ras status (RR,PFS,TTF,Liver resection rate,Liver R0 resection rate,Safety) RR according to smorking habit PFS of bevacizumab-related hypertension with or without | — |
Countries
Japan
Contacts
Public ContactMasayoshi Nakanishi
Kyoto Prefectural University of Medicine Digestive Surgery
Outcome results
None listed