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

Colorectal Neoplasms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272051
• Other study ID #: EFC4972
• Secondary ID: SR57746A
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2006
• Last updated: September 11, 2006
• Start date: July 2002
• Est. completion date: May 2004

Study information

• Verified date: September 2006
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Metastases
• Neurotoxicity Syndromes

Intervention

Drug:
• SR57746A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W
Secondary	Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival

External Links

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