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