Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Phase 2
Completed
- Conditions
- Esophageal Neoplasms
- Interventions
- Registration Number
- NCT00259402
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxaliplatin Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) -
- Primary Outcome Measures
Name Time Method Efficacy endpoints include tumor response, progression free and overall survival. Throughout the whole study
- Secondary Outcome Measures
Name Time Method Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations. Throughout the whole study duration
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇪🇸Barcelona, Spain