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 |
Recruitment Status :
Completed
First Posted : January 4, 2006
Last Update Posted : September 13, 2006
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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 |

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

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
Study Chair: | Gérard SAID, MD | Hôpital de Bicêtre - Le Kremlin-Bicêtre - France |
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 |
Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden |
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 |