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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00305188 |
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.
Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.
Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS))
Condition | Intervention | Phase |
---|---|---|
Metastases Colorectal Neoplasms Colorectal Carcinoma |
Drug: xaliproden (SR57746A) Drug: Placebo Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized Double-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-Line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV |
Estimated Enrollment: | 900 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: xaliproden (SR57746A)
oral administration
Drug: oxaliplatin
in combination with 5-Fluorouracil and Leucovorin
|
2: Placebo Comparator |
Drug: Placebo
oral administration
Drug: oxaliplatin
in combination with 5-Fluorouracil and Leucovorin
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main inclusion criteria :
Exclusion Criteria:
Main exclusion criteria :
United States, Pennsylvania | |
Sanofi-aventis Administrative Office | |
Malvern, Pennsylvania, United States, 19355 | |
Argentina | |
Sanofi-aventis Administrative Office | |
Buenos Aires, Argentina, 1642 | |
Australia | |
Sanofi-aventis Administrative Office | |
Macquarie Park, Australia | |
Brazil | |
Sanofi-aventis Administrative Office | |
Sao Paulo, Brazil, CEP 05677-000 | |
Canada, Quebec | |
Sanofi-aventis Administrative Office | |
Laval, Quebec, Canada | |
Chile | |
Sanofi-aventis Administrative Office | |
Santiago, Chile | |
Germany | |
Sanofi-aventis Administrative Office | |
Berlin, Germany, D-10785 | |
Hungary | |
Sanofi-aventis Administrative Office | |
Budapest, Hungary, H-1325 | |
Italy | |
Sanofi-aventis Administrative Office | |
Milano, Italy, 20 158 | |
Poland | |
Sanofi-aventis Administrative Office | |
Warszawa, Poland, 02-672 | |
Portugal | |
Sanofi-aventis Administrative Office | |
Porto Salvo, Portugal, 2740-244 | |
Spain | |
Sanofi-aventis Administrative Office | |
Barcelona, Spain, 08019 | |
United Kingdom, Surrey | |
Sanofi-aventis Administrative Office | |
Guildford, Surrey, United Kingdom, GU1 4YS |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5505, EUDRACT : 2005-002570-30 |
Study First Received: | March 20, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00305188 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: National Health Service |
Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden |
Digestive System Neoplasms Neurotoxicity Syndromes Gastrointestinal Diseases Colonic Diseases Poisoning Leucovorin Disorders of Environmental Origin Folinic Acid Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Fluorouracil Paresthesia Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neurotoxicity Syndromes Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Disorders of Environmental Origin Rectal Diseases Neoplastic Processes Oxaliplatin Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Digestive System Neoplasms |
Neoplasms by Histologic Type Nervous System Diseases Poisoning Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |