Gastric cancer
Conditions
Interventions
Second-line therapy Ramucirumab(8mg/kg) day 1,15 DIV Paclitaxel(80mg/m2) day 1,8,15 DIV every 28 days Study therapy Ramucirumab(8mg/kg) day 1,15 DIV Irinotecan(150mg/m2) day 1 DIV every
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histrologically proven gastric/esophagogastric junction adenocarcinoma 2)advanced/recurrence 3)age =>20 4)ECOG PS 0 or 1 5)with evaluable lesions 6)previously treated with fluoropyrimidine and platinum 7)within 42 days after failure of fluoropyrimidine and platinum therapy 8)more than 14 days after last infusion of chemotherpy 9)adequate organ functions(according to the labo-data which was taken within 2weeks before registration) 1.WBC =>3,000/mm3 2.neutrophil=>1,500/mm3 3.hemoglobin=>8.0g/dL 4.platelet=>100,000/mm3 5.Total bililubin =<1.5mg/dL 6.AST=<100 IU/l 7.ALT=<100 IU/l 8. Creatinine=<1.5mg/dL or eGFR=>Total bililubin =<1.5mg/dL 10) with written Informed Consent
Exclusion criteria
Exclusion criteria: 1)with active double cancers excluding carcinoma in situ 2)with pleural fluid, ascites or pericardial effusion that requires drainage 3)with ileus or constipation (>=grade 3) 4)with a histroy of uncontrollable hypertension or acute coronary syndrome in 6 months 5)with active gastrointestinal bleeding in 14 days 6)with severe or uncotrollable complications such as diabetes mellitus, bowel obstruction, jaundice, liver dysfunction, psychological illness and severe infectious disease. 7)with active hepatitis B or C 8)with HIV infection 9)with a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 10)with hemorrhagic diathesis or blood coagulation disorder 11)within 28 days after open abdominal or chest surgery or with unrecoverd surgical wounds 12)pregnant and/or nursing women or men who wish to have children in future 13)judged to be unfit to participate in this study by investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement ratio of second registration Treatment continuation rate at eight weeks after second registration Response rate Overall survival Safety Quality of life | — |
Countries
Japan
Contacts
Public ContactYasuyoshi Sato
The University of Tokyo Department of Gastrointestinal Surgery
Outcome results
None listed