Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer

A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.

Inclusion Criteria:

• Diagnosis of adenocarcinoma of the pancreas.
• Pretreatment tumor specimen must be available.
• No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
• Prior radiation allowed.
• Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

Exclusion Criteria:

• Endocrine pancreatic tumor or ampullary cancer.
• Central Nervous System (CNS) metastases.
• Inability to swallow tablets.
• 10% or greater weight loss over the 6 weeks before study entry.