metastatic colorectal cancer
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Lenvatinib
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:24mg
24mg
24m
Sponsors
National Cancer Center Hospital
Department of Gastrointestinal Medical Oncology
Satoru Iwasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically proven colorectal adenocarcinoma 2)Unresectable metastatic colorectal cancer (except for appendiceal and anal canal cancer) 3)Refractory or intolerable to all of the following standard chemotherapy a.Fluoropyrimidines,oxaliplatin,irinotecan and bevacizumab b.Cetuximab or panitumumab in patients with RAS wild-type c.TAS-102 4)No symptomatic brain metastasis and carcinomatous meningitis 5)Oral intake 6)Aged 20 to 79 years 7)Performance Status 0 or 1 8)One or more measurable lesions confirmed by contrast enhanced CT 9)No prior treatment of lenvatinib and regorafenib 10)Not received anti-cancer therapy within 14days before registration 11)Adequately controlled blood pressure 12)Not having any of the following histories/complications a.History of hypertensive crisis or hypertensive encephalopathy b.History of total gastrectomy c.History of surgery under general anesthesia or laparotomy biopsy within 28days before registration d.Unrecovered wound,active gastrointestinal ulcer or bleeding from the primary lesion e.History of congenital hemorrhagic diathesis or coagulation disorder f.Cardiovascular diseases requiring more than 325mg of aspirin daily 13)Adequate organ functions defined as below within 14days before registration a.Neutrophil count >=1500/mm3 b.Platelet count >=100000/mm3 c.Hemoglobin >=8.5g/dL d.Total bilirubin 2+ on urine dipstick testing, <=1g/24hr by 24hr urine collection 14)Given consent to contraception 15)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible 2)Infections requiring systemic therapy 3)Fever of >=38 degrees Celsius at the time of registration 4)Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity 5)Pregnant or breast-feeding women,or women suspected of being pregnant 6)Mental disease interfering taking part in the trial 7)Taking continuous systemic steroids and/or other immunosuppressive drugs(orally or intravenously) 8)HIV antibody positive 9)Interstitial pneumonia and/or pulmonary fibrosis and/or severe pulmonary emphysema diagnosed by chest CT imaging 10)History of any of the followings; unstable angina within 6 months before registration,heart attack,pulmonary embolism,deep vein thrombosis,brain bleeding,cerebral infarction,transient ischemic attacks within 6 months before registration and arterial thromboembolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Adverse events, 2) Overall response rate, 3) Progression-free survival, 4) Overall survival | — |
Countries
Japan
Contacts
Public ContactMamiko Kawasaki
National Cancer Center Hospital
Outcome results
None listed