Unresectable locally advanced pancreatic adenocarcinoma
Conditions
Interventions
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Concur
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed advanced pancreatic cancer 2.Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) 3.Performance Status:0-1(ECOG) 4.Patients of age =>20 and 75> 5.WBC>=3,500/mm3,12,000/mm3, neutrophils >=1,500/mm3, platelets=100,000/mm3, hemoglobin >=9.5 g/dl, GOT </=2.0 X ULN, GPT </=2.0 X ULN, AL-P </=2.0 X ULN, total bilirubin <=1.5mg/dl, serum creatinine <=1.2mg/dl, creatinine clearance>=50 ml/min, PaO2 >=70torr or SpO2 >=96% 6.Life expectancy more than 3 months. 7.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Active infection 2.Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT 3.Severe complication (heart disease, cirrhosis, diabetes) 4.Myocardial infarction within 3 months 5.Active synchronous or metachronous malignancy 6.Pregnant or lactation women, or women with known or suspected pregnancy 7.Symptomatic brain metastasis 8.history of severe drug allergy 9.Peripheral neuropathy 10.Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate, Overall Survival time, Palliative efficacy | — |
Countries
Japan
Contacts
Public ContactTatsuya Ioka
Osaka Medical Center for Cancer and Cardiovascular Diseases Division of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed