metastatic colorectal cancer
Conditions
Interventions
1) Bevacizumab 10mg/kg is administered by 10-30min. intravenous infusion, followed by irinotecan 150mg/m2 by 90 min infusion (2)Patients should be received this chemotherapy biweekly until disease p
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Age: 20 years old or older 3) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4) Histological confirmation of colorectal cancer 5) Life expectancy greater than or equal to 3 months 6)unresectable primary tumor or with one or more unresectable metastatic tumor 7)Measurable or evaluable disease (measurable lesions in RECIST ver1.1 criteria is unnecessary) 8)Progression during or after first line chemotherapy for metastatic disease, including Oxaliplatin based chemotherapy with bevacizumab(over 4 courses) 9)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery >=4 weeks. Radiation therapy >= 4weeks 10)Vital organ functions (listed below) are preserved within 2 weeks prior to entry i) white blood >= 3000/mm3 ii) Neutrophils >= 1500/mm3 iii) Platelets >= 80000/mm3 iv) Hemoglobin >= 8.0 g/dl v) Total bilirubin <= upper limit of normal (ULN) X 1.5 vi) AST and ALT <= ULMX2.5 (5XULM allowed in case of liver metastases) vii) Serum creatinine <= ULM X 1.5mg/dl viii) Protein urea <= 1+
Exclusion criteria
Exclusion criteria: 1)Radiological evidence of CNS metastases or brain cancer 2)Complication of cerebrovascular disease or symptoms within 1 year 3) complication of GI perforation, or past history of perforation within 1 year 4) Uncontroled Gastrointestinal Ulcer 5) Uncontrolled Diarrhea 6) Receiving Atazanavir Sulfate 7)Paralytic or mechanical bowel obstruction 8) Evidence of bleeding diathesis or coagulopathy. 9) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) 10) Clinically significant (i.e. active, CTCAEv4.0 >=Grade2) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11) Uncontrolled Hypertension 12) Need to drain malignant coelomic fluid. 13) Evidence of interstinal lung disease, or pulmonary fibrosi 14) Uncontrolled infection 15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 16) History of the serious hypersensitivity for Fluorouracil or bevacizumab 17) Treatment history of irinotecan 18) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Overall survival Frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactHidekazu Kuramochi
Tokyo Women's Medical University Department of chemotherapy and palliative care
Outcome results
None listed