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)
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