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

• Progression free interval [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Response rate [ Time Frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle ] [ Designated as safety issue: No ]
• Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
• Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

• Progression Free Interval [ Time Frame: 1 year ]
• Response rate [ Time Frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle ]
• Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ]
• Symptoms Improvement [ Time Frame: Assessment every two cycles ]

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.

• Drug: Gemcitabine
  Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
  Other Name: Gemzar
• Drug: Gemcitabine
  Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
  Other Name: Gemzar
• Drug: Erlotinib
  Erlotinib 100 mg by mouth (p.o.), daily until disease progression
  Other Name: Tarceva
• Drug: Oxaliplatin
  Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
  Other Name: Eloxatin

• Experimental: 1
  GEM/TAR
  Interventions:

  • Drug: Gemcitabine
  • Drug: Erlotinib
• Experimental: 2
  GEM/OX/TAR
  Interventions:

  • Drug: Gemcitabine
  • Drug: Erlotinib
  • Drug: Oxaliplatin

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.