XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
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| ClinicalTrials.gov Identifier: NCT00272051 |
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Recruitment Status :
Completed
First Posted : January 4, 2006
Last Update Posted : September 13, 2006
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Sponsor:
Sanofi
Information provided by:
Sanofi
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastases Colorectal Neoplasms Colorectal Carcinoma | Drug: SR57746A | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 620 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| 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) |
| Study Start Date : | July 2002 |
| Study Completion Date : | May 2004 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W
Secondary Outcome Measures :
- Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272051
Sponsors and Collaborators
Sanofi
Investigators
| Study Chair: | Gérard SAID, MD | Hôpital de Bicêtre - Le Kremlin-Bicêtre - France |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00272051 |
| Other Study ID Numbers: |
EFC4972 SR57746A |
| First Posted: | January 4, 2006 Key Record Dates |
| Last Update Posted: | September 13, 2006 |
| Last Verified: | September 2006 |
Keywords provided by Sanofi:
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Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden |
Additional relevant MeSH terms:
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Carcinoma Colorectal Neoplasms Neurotoxicity Syndromes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Nervous System Diseases Poisoning Chemically-Induced Disorders Xaliproden Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |