Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
