Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

Exclusion Criteria

• •Previous chemotherapy for pancreatic cancer.
• •Patients who have recurrent disease within 6 months after pancreaticoduodenectomy or had received adjuvant therapy within 6 months of disease recurrence.
• •Uncontrolled intercurrent illness including:
• •* Active infection
• •* Cardiovascular: New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, blood pressure \> 150/100 mmHg
• •* Clinically significant peripheral vascular disease
• •* History of stroke within previous 6 months
• •* Evidence of bleeding diathesis or coagulopathy
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
• •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
• •Urine protein:creatinine ratio \> 1.0 at screening
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to Day 0
• •Serious, non-healing wound, ulcer, or bone fracture
• •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A computed tomography (CT) scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.
• •Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
• •The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
• •History of any other malignancy in the last 5 years, except patients with a prior history of in situ cancer or basal or squamous cell skin cancer.
• •Peripheral neuropathy \> grade 1
• •Psychiatric illness/social situations that would limit compliance with study requirements