metastatic or recurrent gastric cancer
Conditions
Interventions
Nab-paclitaxel is administered 100mg/m2 given intravenously in a 2-week cycle. Ramurcirumab is administered 8mg per body weight intravenously in a 2-week cycle.
Sponsors
Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)written informed consent got from the patient 2)patient who has histologically or cytologically confirmed gastric adenocarcinoma 3)patient who previously treated with fluorouracil regimens for advanced gastric cancer, and who is refractory or intolerant to them 4)patient with an ECOG Performance Status of between 0 and 1 5)patient is >=20 years old and <80 years old 6)patient who has a life expectancy of at least 90 days 7)patient who has adequate main organ functions in tests within 2 weeks before enrollment a)haemoglobin concentorarion >=8.0 g/dL b)white blood cell(WBC) count >=3,000/mm3 or neutrophil count >=1,500/mm3, and WBC count <=12,000/mm3 c)platelet count >=100,000/mm3 d)serum total bilirubin level <=one and a half times as many as average level baseline e)serum AST and ALT levels two and a half times as many as average level baseline f)serum creatinine <=1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1)patient with allergy of paclitaxel or ramucirumab 2)patient with contraindication for paclitaxel or ramucirumab 3)patient who had previously administered with paclitaxel as first line therapy 4)patient who has a serious infection 5)patient who has serious complications such as heart disease, respitary disorder, cerebrovascular disorder, liver disease and much ascites or pleural effusion 6)patient who has recieved chemotherapy within 2weeks 7)patient who has recieved therapy with blood products 8)patient with other malignat tumor 9)patient with neuropathy (>=grade 2) 10)patient with urinary protein (>=grade 2) 11)patient with brain symptomatic metastasis 12)patient who recieved with steroid 13)patient with psychic disorder 14)patient with pregnancy, lactating or possibility of pregnancy 15)patient who given a dicision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose, recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, overall response rate, disease control rate | — |
Countries
Japan
Contacts
Public ContactTetsuji Takayama
Institute of Biomedical Sciences, Tokushima University Graduate School Gastroenterology and Oncology
Outcome results
None listed