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

• Status: Completed
• Trial end date: 2009-11-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

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