colorectal cancer
Conditions
Interventions
Sponsors
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Disease progression(PD) or difficult to continue for other reason after chemotherapy with Oxaliplatin containing regimen 2)Histological confirmation of colorectal cancer. 3) Advanced or recurrent colorectal cancer that is not amenable to curative resection. 4) Age: 20 years old or more 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 7) Life expectancy greater than or equal to 3 months 8) Vital organ functions are preserved within 14 days prior to entry Patients with UGT1A1 genotype It doesn't have the homo and it has heterozygote of *6,*28. 9) Patient of possible oral ingestion 10) Patient who doesn't have cerebral metastasis 11)Written informed consent 12) Other conditions suitable for this study
Exclusion criteria
Exclusion criteria: 1) Treatment history of irinotecan 2)History of the serious hypersensitivity for Fluorouracil or bevacizumab 3) Treatment with tegafur gimestat otastat potassium Within 7 days 4) Active multiple Primary cancer within 5 years 5)History of adverse events related to DPD loss 6) Uncontrolled diarrhea 7)Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 8)Complication of cerebrovascular disease or symptoms within 1 years 9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS) 10)Evidence of bleeding diathesis or coagulopathy 11)History of thrombosis and embolism,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema 12)Blood transfusion,administration products support or Administering antithrombotic drug within 14 days before enrollment 13)Pleural effusion,ascites,or pericardial effusion requiring drainage 14)Symptom of colorectal obstruction 15)Freash gastrointestinal bleeding,intestinal paralysis or obstruction,uncontrolled complication of peptic ulcer 16) Current or previous (within the last 1 year) history of GI perforation 17)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry (18)Uncontrolled Hypertension and diabetes mellitus (19)Uncontrolled Infection 20)Symptomatic brain metastasis 21)History of central nervous /cerebrovascular accident,uncontrolled mental disturbances 22)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers 23)Receiving Atazanavir Sulfate 24)Paralytic bowel obstruction 25) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I part: To decide Recommended dose Phase II part: Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate,Disease control rate,safety,Overall survival, Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient, | — |
Countries
Japan
Contacts
Public ContactMasataka Ikeda Tsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed