A Phase IB Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

- Predicted life expectancy of >= 12 weeks

- Previous surgery

- Histologically or cytologically confirmed, measurable, locally advanced, unresectable
or metastatic pancreatic adenocarcinoma

- No prior therapy for pancreatic cancer

- Adequate organ and marrow function

- Absolute neutrophil count >= 1.5 x 10^9/L

- Platelets >= 100 x 10^9/L

- Total bilirubin <= institutional upper limits of normal

- AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal

- Serum creatine <= 1.5 x upper limits of normal

- Negative pregnancy test

- Informed consent

- Patient must agree not to smoke while on study

Exclusion Criteria:

- Significant history of cardiac disease unless the disease is well controlled

- Active or uncontrolled infections or serious illness or medical conditions that could
interfere with the patient's ongoing participation in study

- History of any psychiatric condition that might impair the patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent

- History of smoking within the previous 14 days before enrollment or positive cotinine
test at baseline

- Pregnant or breast-feeding females

- Symptomatic brain metastases that are not stable, that require steroids, that are
potentially life-threatening, or that have required radiation within the last 14 days

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to the study drugs