colorectal cancer colorectal cancer
Conditions
Interventions
None listed
Sponsors
Takeshi Yamada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven colorectal cancer 2)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study 4)Patients with unresectable advanced recurrent colorectal cancer who have become refractory or intolerant to fluoropyrimidine anticancer drugs, oxaliplatin, irinotecan, and angiogenesis inhibitors (bevacizumab, ramucirumab, or aflibercept). 5)20 years old 6)ECOG performance status of 0 or 1 7)With measurable lesions according 8)ability to tolerate oral drug administration 9)a life expectancy of at least 3 months 10)Patient who has adequate main organ functions in tests within 14 days beforeenrollment leukocyte >3,000/mm3 neutrophil >1,000/mm3 platelet >75,000/mm3 haemoglobin concentorarion >8.0 g/dL serum total bilirubin level <1.5 mg/dLserum creatinine <1.5 mg/dL serum AST and ALT levels <5x Upper limit of normal (ULN). serum creatinine <1.5 mg/dL Peripheral neuropathy<grade2 Diarrhea and NonHaematotoxicity <grade1 11)gave written informed consent
Exclusion criteria
Exclusion criteria: 1)contraindications for FTD/TPI and Bevacizumab 2)previously received chemotherapy with FTD/TPI 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6)have pleural effusion and ascitic fluid with the treatment 7)Comorbidity or history of heart failure 8)gastrointestinal ulcer or bleeding 9)previous hemoptysis 10)Clinical or radiological evidence of CNS metastases 11)Current or previous (within the last 6 months) history of GI perforation 12)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 13)ongoing treatment with anticoagulant 14)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 15)Under continuous steroid administration 16)decision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate , overall survival, and incidence of Grade 3 neutropenia | — |
Contacts
Public ContactOhta Ryo
Nippon medical school Musashikosugi Hospital
Outcome results
None listed