Inoperable advanced recurrent gastric cancer (2nd line chemotherapy).
Conditions
Interventions
Nab-PTX:260mg/m2 (day1) to be repeated every 3 weeks until meeting the withdrawal criteria. Ramucirumab:8mg/m2 (day1, 15) to be repeated every 2 weeks until meeting the withdrawal criteria.
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological confirmed unresectable advanced or recurrent gastric cancer 2. Prior chemotherapy with more than two weeks 3. ECOG performance status 0-2 4. Age over 20 years old 5. 1st line chemotherapy already have done 6. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration. leukocyte count >=3000/mm3 and <= 12000/mm3 neutrophil count >= 1,500/mm3 platelet count >= 100,000/mm3 hemoglobin level >= 8.5g/dL total bilirbin <= 1.5mg/dL (<=2.5mg/dL with constitutional jaundice) AST and ALT <= 100IU/L, or AST and ALT <= 200IU/L with primary disease serum creatinine <= 1.5mg/dL peripheral neuropaty <= grade 1 7.Cases expected to survive for 90 days or more 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. History of serious allergic drug reaction 2. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 3. history of paclitaxel administration 4. serious complications (pulmonary fibrosis or interstitial pneumonitis, renal failure, liver failure, cerebrovascular accident, ulcer using blood infusion, uncontolable diabetes mellitus) 5. serious infection 6. Massive pericardial effusion, pleural effusion or ascites 7. massive bone metastases 8. brain metastasis including suspicious state 9. Pregnant or lactating female 10. severe disorder of electrocardiogram 11. serious mental disorder 12. Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the accomplishment rate of 3 cycle chemotherapies | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurence frequency and degree of adverse event Disease Control Rate: DCR Response rate: RR Overall survival: OS | — |
Countries
Japan
Contacts
Public ContactTetsuya Okayama
Kyoto Prefectural University of Medicine Department of Gatroenterology and Hepatology
Outcome results
None listed