Gastric cancer
Conditions
Interventions
Sponsors
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gastric adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH- 2) Stage IV 3) ECOG PS 0-1 4) No previous chemothrapy or radiation therapy 5) Laboratory data 1.WBC>=3,000/mimcrol 2.Neutrophil>=1,500/microl 3.Hemoglobin>=8.0 g/dL 4.Platelet>=100,000/microl 5.Total bilirubin<=1.5 mg/dL 6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis) 8.Serum creatinine<=1.3 mg/dL 9.Creatinine clearance>=60 mL/min 10.Ejection fraction on echo cardiogram>=50%
Exclusion criteria
Exclusion criteria: 1) HER2 IHC 3+, or IHC 2 and FISH+ 2) Uncontrolled diabetes 3) Uncontrolled hypertension 4) Unstable angina pectoris, or a history of myocardial infarction within six months 5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Synchronous cancers (except for cases whose prognositc facter is gastric cancer) 7) Systemic infection requiring treatment 8) Fever above 38 degree Celsius 9) A possibility of pregnancy or during pregnancy, or lactating women 10) Psychosis or psychotic symptoms 11) Continuous systemic administration of steroids (oral or intravenous)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free survival Adverse events | — |
Countries
Japan
Contacts
Public ContactOsamu Maeda
Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Outcome results
None listed