colorectal cancer
Conditions
Interventions
Sponsors
Tsuchiura kyodo general hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Written informed consent. (2)Age and Eastern Cooperative Oncology Group (ECOG) performance status (PS) : I.70-74:PS2 II.75<= : PS0-2 (3)Life expectancy greater than or equal to 3 months. (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 during or after first-line chemotherapy for metastatic disease, including bevacizumab with 5FU +/- L-OHP. (8)Vital organ functions (listed below) are preserved within 2 weeks prior to entry. I.Leukocyte count >=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 <=2.0mg/dl VII.Serum creatinine <=1.2mg/dl VIII.Patients with UGT1A1 genotype wild type and *6,*28 heterozygote
Exclusion criteria
Exclusion criteria: (1)Need to drain malignant celomic fluid. (2)Jaundice (3)Paralytic or mechanical bowel obstruction. (4)Receiving Atazanavir Sulfate (5)Radiological evidence of CNS metastases or brain cancer. (6)Multiple primary cancers within 5 years. (7)Complication of cerebrovascular disease or symptoms within 1 year. (8)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (9)Administering antithrombotic drug within 10 days. (10)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). (11)Evidence of bleeding diathesis or coagulopathy. (12)Active gastrointestinal ulcer (13)Current or previous (within the last 1 year) history of GI perforation. (14)Non healing fracture (15)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry. (16)Uncontrolled Hypertension (17)Uncontrolled diabetes mellitus (18)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. (19)History of the serious hypersensitivity for bevacizumab. (20)Evidence of interstinal lung disease, or pulmonary fibrosis. (21)History of organ transplantation. (22)Treatment history of irinotecan. (23)Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I part Estimated the dose limiting toxicities in 1st cycle. Phase II part Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety overall survival overall response rate disease control rate | — |
Countries
Japan
Contacts
Public ContactToshiki Masuishi
Tsuchiura kyodo general hospital Department of Gastroenterology
Outcome results
None listed