Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy

Inclusion Criteria:

• Histologically and/or cytologically confirmed diagnosis of pancreatic ductaladenocarcinoma
• Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0surgical resection
• Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2
• At least 18 years of age
• Adequate bone marrow and organ functions as defined by:
• Absolute neutrophil count ≥ 1000 cells/ μL
• Hemoglobin ≥ 8 g/ dL
• Platelets > 75,000 / μL
• Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
• Total bilirubin ≤1.5 ULN
• AST/ ALT < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN ofnormal
• Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry andfor the duration of study participation. Should a woman become pregnant or suspectpregnancy on study, she must notify her treating physician immediately
• Ability to understand the nature of this study protocol and give written informedconsent.
• Willingness and ability to comply with scheduled visits, treatment plans laboratorytests and other study procedures

Exclusion Criteria:

• Receipt of any investigational agents at the time of registration
• Known, untreated brain metastases
• Presence of metastatic disease or malignant ascites on diagnostic imaging
• Grade two or greater peripheral neuropathy
• Presence of any additional active malignancy within the past 3 years where themalignancy is at least reasonably likely to later the course of therapy, requiresystemic therapy or interfere with imaging assessments
• Uncontrolled intercurrent illness, including significant active infection, symptomaticcongestive heart failure (NYHA classification grade III or IV), unstable angina oractive arrhythmia
• Major surgery within the 4 weeks prior to initiation of study treatment
• A history of allergy or hypersensitivity to any of the study drugs
• Any additional significant medical condition, laboratory abnormality, or psychiatricillness that would prevent the subject from fully participating in the study
• Pregnancy
• Severe hepatic impairment
• Participants with known malabsorption