Advanced Gastric Cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8,15 every 4weeks untile PD.
Sponsors
Tottori University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Patients with prior on chemotherapy incuding fluoropyrimydine (including recurrence within 6 months after last adjuvant chemotherapy) 3) With measurable lesions within 28 days before registration 4) Patients with advanced/recurrent gastric cancer which are resistant to chemotherapy within 28 days before registration 5) ECOG performance status 0, 1 or 2 6) Older than 20 years 7) With longer than 3 months of expected survival at the registration 8) Days before enrollment More than 4 weeks last radiation therapy More than 2 weeks last surgery More than 2 weeks last chemotherapy More than 2 weeks last immunotherapy More than 4 weeks last investigational drug 9) Days before enrollment Leukocyte count =>3,000 /mm3,=< 12000/mm3 Neutrophil count =>1,500/mm3 Platelet count => 100,000/mm3 Hemoglobin => 9.0 g/dL Total bilirubin =<1.5 mg/dL AST and ALTx2.5 of upper limit of normal (ULN) or less Serum creatinine =<1.5 mg/dL 10) Patients were not received a blood transfusion within 14 day before enrollment 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) With history of receiving paclitaxel treatment 2) With peripheral neuropathy greater than Grade2 3) With serious drug allergy 4) With infectious disease and febrile condition (over 38 centigrade) 5) With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 6) With brain metastasis 7) With severe diseases: infectious disease/ uncontrolled DM /poorly controlled hypertension/ myocardial infarction/liver failure/pneumonia or pulmonary fibrosis 8) pregnant or nursing female or male expecting pregnancy of partner 9) Psychological illness 10) Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS),Progression free survival(PFS),Time to progression(TTP),Safty | — |
Countries
Japan
Contacts
Public ContactHiroaki Saitoh
Tottori University Faculty of Medicine Department of Surgery Division of Surgical oncology
Outcome results
None listed