A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
• No prior systemic treatment for metastatic disease
• Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
• Life expectancy ≥12 weeks
• Adequate hematologic, hepatic, and renal function
• Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential

Exclusion Criteria:

• Unstable systemic disease
• Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
• Other malignancy within 5 years prior to study entry
• Significant opthalmologic abnormality
• Inability to take oral medication
• Need for IV alimentation
• Prior surgery affecting absorption
• Active peptic ulcer disease
• Nursing mothers