Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma

Inclusion criteria

• Histologically or cytologically-confirmed pancreatic adenocarcinoma
• Stage IV disease (metastatic only)
• No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
• ECOG performance status of 0-1
• Age >=70 years.
• Evidence of either or both of the following:

• RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter >= 20mm using conventional techniques or >= 10 mm with spiral CT scan)
• An elevated serum CA19-9 at baseline ( >= 2X ULN)
• Female patients must be either surgically sterile or postmenopausal.
• Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
• Adequate bone marrow function:

• ANC >= 1500/uL
• platelet count >= 100,000/uL
• hemoglobin >= 9.0 g/dL
• Adequate hepatic function:

• Total bilirubin <= 1.5 X ULN
• AST (SGOT) <= 2.5 X ULN
• ALT (SGPT) <= 2.5 X ULN
• Adequate renal function as determined by either:

• Serum creatinine <= 1.5 X ULN
• Calculated or measured creatinine clearance >= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
• Ability to understand the nature of this study protocol and give written informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

• Any prior systemic or investigational therapy for metastatic pancreatic cancer.
• Inability to comply with study and/or follow-up procedures.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
• Presence of central nervous system or brain metastases.
• Life expectancy < 12 weeks.
• Pregnancy (positive pregnancy test) or lactation.
• Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Known, existing uncontrolled coagulopathy.
• Pre-existing sensory neuropathy > grade 1.
• Major surgery within 4 weeks of the start of study treatment, without complete recovery.
• Concurrent/pre-existing use of anticoagulant treatment.