Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

Inclusion Criteria:

• Histologically confirmed pancreatic cancer.
• Measurable disease.
• Absence of ascites or obstructive jaundice.
• ECOG Performance Status 0-2.
• Adequate liver kidney and bone marrow function.
• Written informed consent.

Exclusion Criteria:

• Chronic diarrheic syndrome.
• Uncontrolled brain metastases after radiation.
• Liver infiltration over 50%.
• Peripheral neuropathy ≥ 2.
• No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.
• No active uncontrolled infection.
• Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Women who are pregnant or lactating.