colorectal cancer
Conditions
Interventions
Sponsors
Tsuchiura kyodo general hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent. 2.Age :>=20 years 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 4.Histological confirmation of colorectal cancer. 5.Advanced or recurrent colorectal cancer that is not amenable to curative resection. 6.Measurable or evaluable disease. 7.Progression after first-line chemotherapy for metastatic disease, including bevacizumab or anti-EGFR monoclonal antibody with irinotecan. 8.Patients who had a clinical benefit (confirmed stable disease (SD) for at least 6 months or clinical response) in primary treatment with irinotecan. 9.Progression during or after second-line chemotherapy for metastatic disease, including bevacizumab with fluorinated pyrimidine + L-OHP.( In the case of side effects, the treatment by bevacizumab + fluorinated pyrimidine after stopping L-OHP is continuable.) 10.Less than 75mg/m2/week irinotecan in primary treatment was administered.(in the case of the FOLFIRI regimen the dosage of irinotecan was decreased by the start of the 3rd cycle) 11.Vital organ functions (listed below) are preserved within 2 weeks prior to entry. I.Leukocyte >=3,000/mm3 II.Neurtophils >=1,500/mm3 III.Platelets >=100,000/mm3 IV.Hemoglobin >=9.0g/dl V.AST and ALT <= 100IU/l (200IU/l in case of liver metastasis) VI.Total bilirubin <= 2.0ml/dl VII.Serum creatinine <= 1.2mg/dl
Exclusion criteria
Exclusion criteria: (1) Need to drain malignant celomic fluid. (2)Radiological evidence of CNS metastases or brain cancer. (3) Multiple primary cancers within 5 years. (4) Complication of cerebrovascular disease or symptoms within 1 year. (5)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (6) The patient who is planning the surgical treatment during trial. (7)Administering antithrombotic drug within 10 days. (8)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). (9) Evidence of bleeding diathesis or coagulopathy. (10)Active gastrointestinal ulcer (11)Current or previous (within the last 1 year) history of GI perforation. (12)Non healing fracture (13)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry. (14)Uncontrolled Hypertension (15)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. (16)History of the serious hypersensitivity for irinotecan or bevacizumab. (17)Uncontrolled diarrhea (18)Evidence of interstinal lung disease, or pulmonary fibrosis. (19)History of organ transplantation. (20)Uncontrolled infection (21)Pregnant or lactating women or women of childbearing potential. (22) Men without the intention of preventing conception. (23) Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall Survival Total Survival Overall Response Rate Disease Control Rate | — |
Countries
Japan
Contacts
Public ContactToshiki Masuishi
Tsuchiura kyodo general hospital Department of Gastroenterology
Outcome results
None listed