HER2-positive gastric cancer
Conditions
Interventions
S-1/Docetaxel+Trastuzumab
Sponsors
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histopathological diagnosis as gastric adenocarcinoma 2.Unresectable and metastatic gastric cancer 3.HER-2 positive gastric cencer (IHC3+ or IHC2+ and FISH+) 4.Refractory gastric cancer to fluoropirimidine and plutinum agents 5.Age 20-80 years 6.ECOG PS:0-2 7.Case with target lesion or non-target lesion 8.Patient who is possible of ingestion 9.Patient who is expected to be sorvival more than 2 months 10.LVEF>50% by UCG 11. 3000=<WBC=<12000 Neu=>1,500/mm3 Plt=>100,000/mm3 Hb=>8.0 g/dl AST(GOT),ALT(GPT)=>100 IU / l T-Bil=>1.5mg/dl CCr=>50ml/min 12. Informed consent is done by document
Exclusion criteria
Exclusion criteria: 1.Patient with history of chemotherapy by some taxane 2.Patient with history of severe hypersensitivity for some drugs 3.Patient with contraindication of using drugs 4.Patient who needs flucytosine, phenytoin and warfarin 5.Patiet who has active infection with fever over 38 degree 6.Case with active gastrointestinal bleeding 7.Patient with severe concomitant disease 8.Patient with previous or present heart disease 9.Patient with brain metastasis 10.Case with severe pleural effusion or ascites 11.Double cancer 12.Patient with B or C type hepatitis virus 13.Woman with plegnancy or lactation, or woman who will want to be pregnant 14.Man who will want to have a child 15.Investigator's decision as inappropriateness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Progression free survival Overall survival Analysis of molecular marker expression | — |
Countries
Japan
Contacts
Public ContactTakaya Shimura
Nagoya City University Hospital Department of Gastroenterology
Outcome results
None listed