OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

Inclusion Criteria:

• Metastatic pancreatic ductal adenocarcinoma
• Measurable disease
• Life expectancy > 12 weeks
• Normal organ and marrow function
• Fasting blood glucose </= 150 mg/dL
• Able to swallow pills

Exclusion Criteria:

• Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
• Receiving any other experimental agent
• Known brain metastases
• History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
• Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
• Use of enzyme-inducing anti-epileptic drugs
• Diabetes mellitus which requires the use of exogenous insulin for glucose control
• Major surgery within 4 weeks of the start of study treatment
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Use of strong or moderate CYP1A2 inhibitors/inducers
• Pregnant or breast feeding
• History of a different malignancy unless disease-free for at least 3 years
• HIV positive