Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259402
• Other study ID #: EFC_7127
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2005
• Last updated: December 4, 2009
• Start date: February 2000
• Est. completion date: October 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy

Locations

Country	Name	City	State
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoints include tumor response, progression free and overall survival.		Throughout the whole study	No
Secondary	Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.		Throughout the whole study duration	Yes