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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Oxaliplatin; Xaliproden

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