Colorectal Carcinoma, Colorectal Neoplasms, Metastases
Conditions
Keywords
Neurotoxicity syndromes, Paresthesia, Oxaliplatin, Xaliproden
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.
Interventions
DRUGSR57746A
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival | — |
Outcome results
None listed