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Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00305188•Sanofi

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

•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.

Locations (13)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Sanofi-Aventis Administrative Office

Laval, Canada

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Berlin, Germany

Sanofi-Aventis Administrative Office

Budapest, Hungary

Sanofi-Aventis Administrative Office

Milan, Italy

Sanofi-Aventis Administrative Office

Warsaw, Poland

Key Dates

Start Date

December 1, 2005

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

May 4, 2016

Enrollment

879

ACTUAL participants

Conditions

MetastasesColorectal NeoplasmsColorectal Carcinoma

Interventions

Xaliproden (SR57746A)

DRUG

Placebo

DRUG

Oxaliplatin

DRUG

5-Fluorouracil

DRUG

Leucovorin

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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