Gastric cancer
Conditions
Interventions
nab-paclitaxel
Sponsors
Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histlogically confirmed gastric adenocarcinoma 2) Unresectable or recurrent gastric cancer 3) No previous chemotherapy for other malignancies 4) Prior chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer 5) No past history of treatment related taxan 6) Age : 20 years old and more 7) ECOG Performance Status 0-2 8) Liffe expectancy : 90 days and more 9) Adequate organ function as evidenced by the follow laboratory studies within 28 days prior to enrollment a)Neutrophil conunt : 1,500 /mm3 or above b)Platet count : 100,000 /mm3 or above c) Hemoglobin : 8.0 g/dL or above d) Total bilirubin : 1.5 mg/dL or less e) AST(GOT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis) f) ALT(GPT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis) g) Serum creatinine : 1.5 mg/dL or less 10) Tumor tissue can be used for this study 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Multiple primary cancers with disease-free period less than 5-years, except carcinoma in situ or intra mucosal disease cured by local therapy 2) Past history of severe hypersensitivity to drug 3) Active incection 4) Fever more than 38 degree 5) Central nervous system metastasis or carcinomatous meningitis 6) Massive cardiac effusion, pleural effusion or ascites 7) Peripheral sensory neuropathy : grade 2 or above (CTCAE v4.0) 8) Chronic daily treatment with oral or intravenous corticosteroids 9) Unstable angina or past history of myocardinal infraction in 6 months 10) Evidence of any other serious disease ; renal failure, hepatic failure, interstinal pneumonitis or lung fibrosis 11) Pregnant, lactating female, female of childbearing potential or male without contracepcion intention 12) Psychiatric disease that is inapprocpriate for entry into this study 13) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival according to SPARC expression | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival Time to Treatment Failure Response Rate Disease Control Rate Dose Intensity Adverse Event Clinicopathological Characteristics of SPARC expression | — |
Countries
Japan
Contacts
Public ContactKei Onodera
Sapporo Medical University Department of Gastroenterology, Rheumatology and Clinical Immunology
Outcome results
None listed