EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

Inclusion Criteria:

• Inoperable adenocarcinoma of the pancreas
• Histologic or cytologic confirmation
• At least 18 years of age

Exclusion Criteria:

• Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
• Major surgery within 4 weeks prior to enrollment
• Major cardiovascular disease