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

Inclusion Criteria:

* 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).