Metastatic colorectal cancer
Conditions
Interventions
Arm A: Bevacizumab+FOLFIRI
(1) BEV 5 mg/kg iv (over 10 minutes) day 1
(2) l-LV 200 mg/m2 iv (2hr) day 1
(3) IRI 150 mg/m2 iv (90min) day 1
(4) 5-FU 400 mg/m2 bolus day 1
(5) 5-FU 2,400 mg/m2/46h conti
Sponsors
HIRONAKA Shuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colorectal adenocarcinoma. 2) Unresectable or reccurent colorectal cancer diagnosed by imaging. 3) The main tumor location is cecum (C), ascending colon (A), transverse colon (T), descending colon (D), sigmoid colon (S), rectal sigmoid (RS),upper rectum (Ra), or lower rectum (Rb). 4) RAS mutation status has been confirmed on RAS mutation analysis. 5) BRAF (V600E) wild. 6) Microsatellite stable and/or Proficient DNA mismatch repair 7) Aged 20 years and older at the time of enrollment. 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9) Having measurable lesion 10) No history of prior irinotecan or ramucirumab or aflivercept. 11) Refractory or intolerance to first-line treatment contained fluoropyrimidine and oxaliplatin 12) No severe stenosis by primary tumor 13) No bowel stenosis due to peritoneal dissemination. 14) No massive ascites or pleural effusion at the time of enrollment. 15) No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration. 16) No CNS involvement including brain metastasis 17) Main organ functions maintained on examinations performed within 14 days before enrollment 18) Written informed consent to blood sampling for analysis of biomarker 19) Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous ( within 5 years ) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy. 2) Active infection requiring systemic therapy. 3) Fever of 38 degrees Celsius or higher. 4) Pregnant or lactating women, women of childbearing potential, or women within 28 days after delivery. 5) Psychiatric disease. 6) Patients requiring systemic steroids medication. 7) Uncontrollable diabetes mellitus 8) Inadequately controlled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg on anti-hypertensive medications. 9) Inadequately controlled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg on anti-hypertensive medications. 10) Uncontrollable levofolinate, dilated cardiomyopathy, or hypertrophic cardiomyopathy 11) Severe diarrhea 12) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 13) History of unstable angina, myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral hemorrhage, cerebral infarction, transient ischemic attack (TIA), cerebrovascular disturbance, or arterial thromboembolism. 14) Known hypersensitivity to any of the component of Fluorouracil, levofolinate, or bevacizumab. 15) Receiving Atazanavir Sulfate contraindication for irinotecan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Response rate, Adverse events, Serious adverse events | — |
Contacts
Public ContactShuichi HIRONAKA
Kyorin University Hospital
Outcome results
None listed