GEMOX: Oxaliplatin in Pancreatic Cancer

Launched by SANOFI · Dec 1, 2005

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.