Gemcitabine/Cisplatin +/-Cetuximab in Patients With Locally Advanced or Metastatic EGFR-Positive Pancreatic Cancer

• Age ≥ 18 years
• Histologically confirmed diagnosis of adenocarcinoma of the pancreas
• Locally advanced (non-resectable) or metastatic pancreatic cancer
• Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
• Immunohistochemical evidence or positive EGFR expression prior to study entry in primary tumor and/or at least one metastasis
• Life expectancy of ≥ 3 months
• Karnofsky performance status of ≥70 at study entry
• Neutrophils ≥ 1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥ 9 g/dL
• Bilirubin level either normal or \< 1.5 x ULN
• ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
• Serum creatinine \< 1.5 x ULN
• Effective contraception for both, male and female patients if the risk of conception exists
• Signed written informed consents prior to beginning protocol specific procedures

Exclusion Criteria:

• Brain metastasis
• Previous chemotherapy for locally advanced or metastatic pancreatic cancer
• Adjuvant therapy is allowed if recurrence is documented > 6 months after the end of adjuvant treatment
• Radiotherapy within 4 weeks prior to study entry
• Concurrent chronic systemic immune therapy
• Any investigational agent(s) 4 weeks prior to entry
• Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse/ alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).