XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy

Study Overview
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Brief Summary
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Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.

Official Title
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A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)

Conditions
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Metastases, Colorectal Neoplasms, Colorectal Carcinoma

Intervention / Treatment
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* Drug: SR57746A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven adenocarcinoma of the colon or the rectum age > 18 years WHO performance status : 0,1,2 Signed written informed consent prior to study entry Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease) Measurable disease No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months) Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study Exclusion Criteria: Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy Prior therapy with Oxaliplatin History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency History of intolerance to appropriate antiemetics Concurrent active cancer originating from a primary site other than colon or rectum Presence of any symptom suggesting brain metastasis Known peripheral neuropathy Interstitial pneumonia or extensive and symptomatic fibrosis of the lung Allergy to Xaliproden/excipients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SR57746A|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurotoxicity syndromes, Paresthesia, Oxaliplatin, Xaliproden