Patients with gemcitabine-refractry advanced pancreatic cancer.
Conditions
Interventions
Group A : Gemcitabine 1,000mg/m2 is administered with for 30-min intravenous infusion on day 1, 8 and 15 every 4 weeks.
Group B : Best available fluoropyrimidine therapy : Each institute can choose f
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology Pancreatic cancer study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed pancreatic ductal carcinoma. 2) Patients of age =>20 and 80> 3) Performance Status:0-2(ECOG) 4) Life expectancy more than 1 months. 5) Adequate organ functions. neutrophils >=2,000/mm3 leukocytes =>4,000 and 12,000/mm3> platelets >=100,000/mm3 hemoglobin >=9.5g/dl AST(GOT)/ALT(GPT) <=LLN x2.5 total bilirubin <=LLN x2 serum creatinine <= LLN BUN <= LLN PaO2 >= 70 torr 6) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings. 2) Severe infection. 3) Severe complication. (heart failure, angina pectoris, arrhythmia, diabetes , intestines paralysis, ileus, myocardial infarction within 6 months after the onset.) 4) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy. 5) Watery diarrhea. 6) Jaundice. 7) Uncontrolled pleural or abdominal effusion. 8) Severe drug hypersensitivity. 9) History of other active malignancy. 10) Severe mental illness 11) Patients who are judged inappropriate for the entry into the study by the investigater.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Survival Time of 2nd line therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Response (CBR) Safety Time To Progression (TTP) Overall Survival (OS) | — |
Countries
Japan
Contacts
Public ContactTatsuya Ioka
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Outcome results
None listed