Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients

• To determine the activity and efficacy of the schema specified as dose regimen
• To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

Inclusion Criteria:

• ECOG 0-1
• Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
• No previous treatment with chemotherapy or radiotherapy
• Measurable lesion (uni or bidimensional)

Exclusion Criteria:

• Creatinin clearance <50 mL/min
• Total bilirubin >1.5*ULN (Upper Limit of Normal)
• AST/ALT > 2.5*ULN
• Total White Blood Cell <1.500.000/mL
• Platelet count <100.000.000/mL
• symptomatic sensitive peripheral neuropathy
• pregnant or breast-feeding women

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