First-Line Gemcitabine Chemotherapy With Our Without Sunitinib In Advanced or Metastatic Pancreatic Cancer

Exclusion Criteria

• •Resectable pancreatic cancer
• •Previous chemotherapy (for adjuvant or metastatic disease)
• •Any investigational drug within the 30 days before inclusion.
• •Prior use of sunitinib or other multitarget tyrosine kinase inhibitor
• •Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
• •Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
• •Clinically symptomatic brain or meningeal metastasis. (known or suspected)
• •Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
• •History of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (CHF) \> NYHA Class II; cerebrovascular accident or transient ischemic attack; pulmonary embolism
• •Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of up to 3 anti-hypertensive drugs
• •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
• •Previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[Ta, Tis and T1\].
• •History of organ allograft
• •Patients requiring long-term cortisone therapy
• •Patients requiring oral anticoagulation treatment (such as marcoumar)