unresectable pancreatic cancer
Conditions
Interventions
Phase I: 24 weeks Phase II: until disease progression, unacceptable toxicity, or patient refusal
Sponsors
Kobe University Hospital Department of Hematology and Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological diagnosis of pancreatic cancer and unresectable pancreatic cancer or non-curative resection except for chemotherapy and radiotherapy or recurrence of curative resection 2.over 20 years old 3.ECOG PS 0 or 1 4.one more measurable lesions based on RECIST 5.no previous treatment of chemotherapy,radiotherapy and immunotherapy except for biliary drainage 6. major organ function is held 1.Neutrophil count is over 500 per mm3 2.Hb is over 9.0g per dL 3.Platelet count is over 100000 per mm3 4.T.Bil is under one and a half times Reference value upper limit 5.AST,ALT is under 3 times Reference value upper limit 6.Ccr is over 60ml per min 7.no serious complications 8.ingestible 9.CIPN is under Grade1 10.consent is obtained
Exclusion criteria
Exclusion criteria: 1.Interstitial pneumonitis or pulmonary fibrosis 2.uncontorolled diabetes, liver failure, angina pectoris,myocardial infarction within 3 months after the onset 3.severe infection 4.pregnant woman,lactation,possibility or intention of pregnancy 5.serious drug allergy 6.psychiatric symptoms or mental illness 7.Moderate or severe ascites, pleural effusion 8.uncontrolled watery diarrhea 9.unsuitable for safely carrying out this trial 10.double cancer affected performance status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 part: determination of maximum tolerated dose and recommended dose Phase 2 part: response rate | — |
Countries
Japan
Contacts
Public ContactYoshiaki Nagatani
Kobe University Hospital Department of Hematology and Oncology
Outcome results
None listed