Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

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

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