Colorectal cancer
Conditions
Interventions
Bevacizumab
Sponsors
Saitama medical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed adenocarcinoma of colon or rectum. 2) Unresectable locally advanced or metastatic disease. 3) Age is over 20 years. 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 5) Patinets with or without measurable or evaluable lesion are eligible. 6) Without history of bevacizumab chemotherapy, without more than 2 chemotherapys, no chemotherapy 4 weeks prior to bevacizumab treatment. History of adjuvant chemotherapy administrated bofore 6 months exclude from prior chemotherapy. 7) Adequate organ function, evidenced by following laboratory results within 14 days prior to randamization. Leukocyte count<12,000cells/mm3 Absolute neutrophil count<2,000/mm3 Hemoglobin<9.0g/dl Platelet count<100,000/mm3 Total bilirubin<1.5mg/dl AST and ALT<2.5 times the upper limit of normal(ULN) Creatinine<1.5mg/dl Urine protein/urine creatinine ratio<1.0 8)Signed, written informed concent is obtained.
Exclusion criteria
Exclusion criteria: 1) Current severe infeciton, or suspicious of severe infection with fever greater than 38 degrees centigrade. 2) Sensory neuropathy. 3) Uncontrollable diabetes 4) Uncontrollable hypertension 5) Severe abnormality in electrocardiogram, or cardiovascular disease (e.g., heart failure, angina) with clinical symptom 6) Severe pulmonary disease (e.g., interstitial pneumonia, pulmonary fibrosis, severe pumonary emphysema) 7) Severe systemic disease(e.g., ileus, renal failure, hepatic failure) 8) Clinical or radiographic evidence of brain metastases 9) History of thromboembolism(e.g, myocardial infarction, cerebral infarction, deep venous thromboembolism, pulmonary thrmboembolism) 10) Uncontrollable gastrointestinal ulcer 11) Carcinomatous peritonitis controlled with drainage 12) Any surgery within 4weeks prior to randamization(the exception of implanted port system) 13) Clinical evidence or potential of dysfunction of coagulation 14) Current daily treatment with warfarin 15) Active synchronous cancer 16) Current known infection with HBV or HCV 17) Pregnant or lactating women, or men and women without wanting pregnancy 18) Severe psychiatric disorder 19) Current daily treatment with corticosteroid 20) Severe hypersensitivity to medicine(hypersensitivity to platinum, fluorouracil or 5-HT3 receptor antagonist is ineligible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify whether the biomarkers in blood or urine predict bevacizumab associated hypertension and proteinuria. | — |
Countries
Japan
Contacts
Public ContactToshikado Kaneta
Saitama medical university Department of medical oncology
Outcome results
None listed