Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

December 4, 2009 updated by: Sanofi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy endpoints include tumor response, progression free and overall survival.
Time Frame: Throughout the whole study
Throughout the whole study

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.
Time Frame: Throughout the whole study duration
Throughout the whole study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: JOSÉ Mª TABOADA, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC_7127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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