Colorectal cancer
Conditions
Interventions
TFTD: 35 mg/m. given orally twice daily on days 1-5 and 8-12 in a 28-day cycle Bevacizumab: 5 mg/kg, administered by intravenous infusion for 30 min every 2 weeks
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed advanced or recurrent colorectal adenocarcinoma (exclude appendix and anal cancer) 2.Unresectable colorectal cancer confirmed by imaging 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4.Confirmed RAS mutation status 5.Treatment history of one or more regimens of standard chemotherapy (1) Refractory or intolerant to fluoro pyrimidine, irinotecan, oxaliplatin, angiogenesis inhibitor (bevacizumab, ramucirumab, or aflibercept), and anti-EGFR antibody (cetuximab or panitumumab) for wild-type RAS (2) Exclude history of intolerance to bevacizumab (3)Include history of adjuvant chemotherapy if a tumor had relapsed within 6 months after the last administration 6 No treatment history of regorafenib and TFTD 7.Measurable lesions based on the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) within the 21 days before enrolment 8.Adequate bone marrow,hepatic,and renal functions 9.Written informed consent
Exclusion criteria
Exclusion criteria: 1.History of intolerance to bevacizumab 2.Thromboembolic events within the 6 months before enrolment 3.Active bleeding 4.Severe heart disease within the 6 months before enrolment 5.Cerebrovascular events 6.Active infections 7.Ascites, pleural effusion, or pericardial effusion requiring treatment 8.Gastrointestinal obstruction, renal failure, or liver failure 9.Uncontrolled diabetes mellitus 10.Uncontrolled hypertension 11.Positive for Hepatitis B surface antigen (HbsAg+) or Hepatitis C antibody (HCV Ab+) 12.Other active cancer 13.Symptomatic brain metastases 14.Requiring immunosuppressive treatment due to an autoimmune disorder or history of organ transplantation 15.Treatment history; (1)Major surgery (i.e., thoracotomy or laparotomy) within the 4 weeks before enrollment (2)Chemotherapy within the 2 weeks before enrollment (3)Extensive exposure of radiation within the 4 weeks before enrollment 16.Unresolved adverse events of grade 2 or higher (classified with the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from previous treatment 17.Unhealed wound or traumatic fracture 18.tendency of haemorrhage and undergoing treatment with an antithrombotic drug (including a daily dose of 325 mg or more of oral aspirin) 19.Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential 20.Clinically significant mental or psychological disorder 21.Patients whose participation in the trial was judged to be inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) by RAS mutation status | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR in full analysis set Progression-free survival Overall survival Objective response rate Safety Efficacy and safety by the BRAF mutation status (exploratory outcome) | — |
Countries
Japan
Contacts
Public ContactTAKAO TAKAHASHI
Gifu University, Graduate School of Medicine Department of Surgical Oncology
Outcome results
None listed