GEMOX: Oxaliplatin in Pancreatic Cancer

Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Primary objective:

• To evaluate overall response rate (based on RECIST criterion)

Secondary objective:

• To evaluate time to progression, clinical benefit, quality of life and safety

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

Exclusion Criteria:

• Corticotherapy except for anti-emetic purpose
• Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
• Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
• Uncontrolled or persistent hypercalcemia
• History of significant neurologic or psychiatric disorders
• Vater ampulomas and biliary tract adenocarcinomas
• Other -non cured- malignancies

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.