GEMOX: Oxaliplatin in Pancreatic Cancer

Inclusion Criteria

• •Histologically proven adenocarcinoma of the pancreas
• •Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
• •Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors\>2cm using conventional CT scan or ≥1cm with spiral CT scan)
• •No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
• •Karnofsky Performance Status (KPS) ≥60
• •No known Central Nervous System metastases
• •No sensory neuropathy at inclusion
• •Biological and hematological evaluation \< 2 weeks prior to treatment administration:
• •* Neutrophils ≥ 1500/ mm3
• •* Platelets ≥ 100,000/mm3
• •* Alkaline phosphatases\< 5X ULN(upper Limits of Normal) and Bilirubin \< 1.5X ULN
• •* SGOT,SGPT \<2.5 X ULN if no liver metastasis
• •* SGOT,SGPT \<5 X ULN if liver metastasis
• •* Creatinine \< 1.5 X ULN
• •Baseline imaging (CT scan or Magnetic Resonance Imaging) \<3 weeks before treatment administration
• •Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children