Status:
COMPLETED
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
Lead Sponsor:
Sanofi
Conditions:
Metastases
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 object...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT00272051
Start Date
July 1 2002
End Date
May 1 2004
Last Update
September 13 2006
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