unresectable pancreatic cancer
Conditions
Interventions
Irinotecan: dose escalation S-1: dose escalation Oxaliplatin: fixed dose
Sponsors
Department of Gastroenterology Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed Adenocarcinoma or Adenosquamous carcinoma 2. Aged 20 to 75 years old 3. ECOG PS of 0 or 1 4. Life expectancy > 3 months. 5. Sufficient oral intake 6. Unresectable 7. The subject has measurable disease. 8. No prior therapy for pancreatic cancer 9. Adequate organ functions 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with contraindication for the medication of Irinotecan, S-1 and L-OHP 2. History of serious drug hypersensitivity or a history of drug allergy 3. Pregnancy 4. Active infection 5. Severe complications 6. Peripheral neuropathy 7. Serious diarrhea 8. Intestinal pneumonitis or pulmonary fibrosis 9. Much ascites or pleural effusion or pericardial effusion 10. Active double cancer 11. Symptomatic brain metastasis 12. Regular use of frucitocin, fenitoin or warfarin 13. Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 14. HBV carrier who has to take nucleotide analogues during chemotherapy 15. Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I : MTD, RD Phase II : response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, progression-free survival | — |
Countries
Japan
Contacts
Public ContactKosuke Okuwaki
Kitasato University School of Medicine Department of Gastroenterology
Outcome results
None listed