Circulating Tumor Cells as Tools for Therapy Response in Nab-paclitaxel Treated Metastatic Pancreatic Cancer Patients (PACT-ACT-v6)

Inclusion Criteria:

• Male or female > 18 years up to 80 years
• Histologically or cytologically proven adenocarcinoma of the pancreas before start of treatment. Also patients for whom there is a strong suspicion of unresectable pancreatic cancer will before the diagnosis is confirmed be asked for consent to take 2 additional biopsies at the time of diagnostic biopsy retrieval, in case the histological analysis confirms that they can be included.
• Locally advanced (primarily unresectable) and/or metastatic disease.
• Presence of at least one measurable lesion according to the RECIST criteria, not restricted to previously irradiated area or limited to bone, pleural effusion or ascites.
• ECOG/WHO performance status ≤2
• Absolute neutrophil count (ANC) >1.5 x 109 /L and platelet count >100 x 109/L
• Total bilirubin < 1.5 times the upper limit of the normal range at the institution (ULN) or AST or ALT < 2 x ULN. If liver metastases are present, patients can be included if total bilirubin < 5× ULN or AST/ALT <10× ULN. Dose reductions of paclitaxel will be performed when bilirubin >2xULN, depending on increase of the bilirubin level according to the recommendations of the Summary of Product Characteristics.
• Serum creatinin < 1,5 ULN / calculated creatine clearance > 60 ml/min.
• Written informed consent

Exclusion Criteria:

• Current infection, bowel obstruction or subobstruction, or other uncontrolled intercurrent illness.
• Prior medical treatment for advanced pancreatic cancer
• Confirmed brain metastasis.
• Concurrent or past history of another malignancy except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix.
• Treatment with any other investigational drug more than 30 days prior to study entry.
• Allergy to anyone of the included drugs.
• Female patient breast feeding or pregnancy
• Not able/ or not willing to use adequate contraception (defined below). A pregnancy test will be included in the baseline visit for women of childbearing potential.