JPRN-UMIN000022964
Completed
Phase 1
A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer - IRISOX for gemcitabine-refractory pancreatic cancer
Kitasato University School of Medicine0 sites12 target enrollmentJuly 1, 2016
Conditionsgemcitabine-refractory pancreatic cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- gemcitabine-refractory pancreatic cancer
- Sponsor
- Kitasato University School of Medicine
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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