gemcitabine-refractory pancreatic cancer
Conditions
Interventions
CPT-11: dose escalation S-1: fixed dose L-OHP: fixed dose
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically proven Adenocarcinoma or Adenosquamous carcinoma 2.resistant /intolerable to gemcitabine 3.with a rest longer than 14 days after the end of prior therapy 4.Age 20-75 5.ECOG PS of 0-1 6.expected survival period longer than 2 months 7.Sufficient oral intake 8.The subject has measurable disease. 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 (Grade 3,4 CTCAE v4.0) 6.Peripheral neuropathy(Grade 2,3,4 CTCAE v4.0) 7.Serious diarrhea(Grade 2,3,4 CTCAE v4.0) 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.Active Hepatitis B 15.Inappropriate for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: MTD, RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Response rate, Progression free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactKosuke Okuwaki
Kitasato University School of Medicine Department of Gastroenterology
Outcome results
None listed