Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

April 6, 2016 updated by: Sanofi

A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV

Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.

Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.

Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

879

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Poland
      • Warszawa, Poland
        • Sanofi-Aventis Administrative Office
  • Portugal
      • Porto Salvo, Portugal
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Main inclusion criteria :

  • Histologically or cytologically-proven metastatic cancer of the colon or rectum.
  • Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
  • Male or female aged >18 years.
  • WHO Performance Status (PS) : 0 or 1.
  • Measurable disease.
  • No prior chemotherapeutic regimen for metastatic disease.
  • Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
  • Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
  • Signed written informed consent prior to study entry.

Exclusion Criteria:

Main exclusion criteria :

  • Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
  • Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
  • Peripheral neuropathy >Grade 1.
  • Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
  • Concurrent active cancer originating from a primary site other than colon or rectum.
  • Presence of any symptom suggesting brain metastasis.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
oral administration
Drug: Oxaliplatin
IV administration
Drug: 5-Fluorouracil
IV administration
Other Names:
  • 5-FU
Drug: Leucovorin
IV administration
Other Names:
  • LV
Experimental: Xaliproden (SR57746A)
Drug: Xaliproden (SR57746A)
oral administration
Drug: Oxaliplatin
IV administration
Drug: 5-Fluorouracil
IV administration
Other Names:
  • 5-FU
Drug: Leucovorin
IV administration
Other Names:
  • LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Time Frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Q2W during treatment, Q4W to Q12W during post-treatment follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Main: response rate using RECIST criteria
Time Frame: Q8W
Q8W
Other: nerve conduction studies
Time Frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Time Frame: Q8W and study period
Q8W and study period

Collaborators and Investigators

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

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5505
  • EUDRACT : 2005-002570-30

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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