Back to resultsOxaliplatin in Esophagus Cancer (Advanced) 1st Line
Primary Purpose
Esophageal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxaliplatin
Arm Description
Outcomes
Primary Outcome Measures
Efficacy endpoints include tumor response, progression free and overall survival.
Secondary Outcome Measures
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00259402
Brief Title
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Official Title
Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxaliplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
Intervention Description
OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
Primary Outcome Measure Information:
Title
Efficacy endpoints include tumor response, progression free and overall survival.
Time Frame
Throughout the whole study
Secondary Outcome Measure Information:
Title
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
Time Frame
Throughout the whole study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Mª Taboada
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
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