A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Phase 1
- Conditions
- gemcitabine-refractory pancreatic cancer
- Registration Number
- JPRN-UMIN000022964
- Lead Sponsor
- Kitasato University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: MTD, RD
- Secondary Outcome Measures
Name Time Method Safety, Response rate, Progression free survival, Overall survival