Metastatic pancreatic cancer
Conditions
Interventions
Pegfilgrastim
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma 2)ECOG Performance Status 0-1 3)Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1 4)Meets the following criteria within 7days before enrollment hemoglobin: >9 g/dL absolute neutrophil: >2000/mm3 platelet count: >100,000/mm3 AST and ALT: <2.5 X ULN total bilirubin: <ULN serum creatinine: <1.2mg/dL 5)written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Prior radiotherapy or chemotherapy 2)Grade 2 or greater peripheral neuropathy 3)Blood transfusion, administration of blood products, or hematopoietic (e.g., G-CSF) support within 7 days before enrollment 4)UGT genetic polymorphisms of homozygous UGT1A1*6 or UGT1A1*28 or heterozygous UGT1A1*6 and *28 5)confirm the presence of ascites or peritoneal metastasis by imaging 6)Intestinal pneumonitis or pulmonary fibrosis 7)severe diarrhea within 3 days before enrollment 8)Clinically significant heart disease 9)Active infection (except HBV+,HCV+) 10)Poor glycemic control diabetes mellitus 11)Serious complications (organ failure, or active peptic ulcer etc) 12)Severe mental disorder, or central nervous system disorders 13)Serious drug allergy 14)Active double cancer 15)Brain or meningeal metastasis 16)Pregnancy 17)Treatment with atazanavir sulfate 18)Inappropriate for this study judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of febrile neutropenia during the first 3 cycles of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Progression Free Survival, Response Rate, Relative Dose Intensity, Adverse events, Severe adverse events | — |
Countries
Japan
Contacts
Public ContactMitsuhito Sasaki
National Cancer Center Hospital Department of Hepatobiliary Pancreatic Oncology
Outcome results
None listed