Status:
COMPLETED
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Lead Sponsor:
Sanofi
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
* 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00259402
Start Date
February 1 2000
End Date
October 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Barcelona, Spain