Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients

Inclusion Criteria

• •1. Aged above 21
• •2. Histopathological diagnosis of pancreatic cancer
• •3. Advanced disease not amenable to curative resection (locally advanced or metastatic disease)
• •4. Measureable disease by RECIST 1.1 criteria
• •5. Life expectancy of at least 12 weeks
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• •7. Adequate hematologic function (granulocyte count ≥ 1.5 × 10\*\*9/L, platelet count ≥ 100 × 10\*\*9/L),
• •8. Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal \[ULN\], AST and ALT, ALP ≤ 3 x ULN or \< 5 x ULN in case of hepatic involvement),
• •9. Adequate renal function (creatinine clearance \> 50 mL/min) will be eligible for inclusion into the study.
• •10. Able to provide written and informed consent
• •2. Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or MRI brain is only required if there is clinical suspicion of CNS involvement.
• •3. Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
• •4. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
• •5. Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study
• •6. Major surgery within two weeks prior to enrolment into the study
• •7. Patients on chronic immunosuppressive therapy
• •8. Pregnancy, lactation or inadequate contraception. Women of childbearing potential must have a negative pregnancy test within 3 days of enrolment and agree to use a reliable means of contraception. Men must have been surgically sterilised or agree to use a barrier method of contraception
• •9. Patients on anticoagulant therapy with vitamin K antagonists.