Metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti-epidermal growth factor receptor(EGFR) antibodies
Conditions
Interventions
TAS-102 35 mg/m2, orally BID The evening of Day 1 to the morning of Day 6,Evening of Day 8 to the morning of Day 13, every 28 days Cetuximab Initial dose is 400 mg/m2, the subsequent weekly dose
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histopathologically confirmed unresectable or metastatic colorectal adenocarcinoma 2) Wild-type RAS status 3) Measurable disease by response evaluation criteria in solid tumors (RECIST version 1.1) criteria 4) refractory disease or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin) and antiangiogenic agent (bevacizumab,ramucirumab and aflibercept) , and refractory to anti-EGFR antibodies (cetuximab and panitumumab) 5) No prior TAS-102 6) Patients who have not had major surgery (i.e., thoracotomy or laparotomy) within 4 weeks prior to enrollment. 7) Patients who have not had radiotherapy for bone and/or brain metastases excluding primary colorectal cancer within 2 weeks prior to enrollment 8) Patients who have not had any chemotherapy within 2 weeks prior to enrollment 9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 10) An estimated life expectancy of at least 12 weeks after enrollment 11) Is able to take medications orally 12) Patients must have the following adequate organ functions 13) Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1) Previous grade 3/4 hypersensitivity reaction to Cmab 2) Another malignancy with less than 5 disease-free years 3) Presence of active local or systemic infection under treatment 4) Positive for Hepatitis B surface antigen 5) Radiographic evidence of severe pulmonary fibrosis or interstitial pneumonia on Computed Tomography 6) Symptomatic brain and/or leptomeningeal metastases which needs treatment 7) Serious complications 8) Clinically significant mental or psychological disorder 9) Patients requiring continuous treatment with systemic steroids 10) Females who are pregnant, breastfeeding, or with a positive pregnancy test or males and females of reproductive potential unwilling to use adequate contraception 11) Patients whose participation in the trial was judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival , progression free survival , response rate , safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed