This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with 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 creatinine <= 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

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.