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Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00305188
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : May 4, 2016
Information provided by (Responsible Party):

Brief Summary:

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)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Condition or disease Intervention/treatment Phase
Metastases Colorectal Neoplasms Colorectal Carcinoma Drug: Xaliproden (SR57746A) Drug: Placebo Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Leucovorin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 879 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Xaliproden (SR57746A) Drug: Xaliproden (SR57746A)
oral administration

Drug: Oxaliplatin
IV administration

Drug: 5-Fluorouracil
IV administration
Other Name: 5-FU

Drug: Leucovorin
IV administration
Other Name: LV

Placebo Comparator: Placebo Drug: Placebo
oral administration

Drug: Oxaliplatin
IV administration

Drug: 5-Fluorouracil
IV administration
Other Name: 5-FU

Drug: Leucovorin
IV administration
Other Name: LV

Primary Outcome Measures :
  1. Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment [ Time Frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up ]

Secondary Outcome Measures :
  1. Main: response rate using RECIST criteria [ Time Frame: Q8W ]
  2. Other: nerve conduction studies [ Time Frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug ]
  3. Other: progression free survival and survival [ Time Frame: Q8W and study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Main inclusion criteria :

  • Histologically or cytologically-proven metastatic cancer of the colon or rectum.
  • Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
  • Male or female aged >18 years.
  • WHO Performance Status (PS) : 0 or 1.
  • Measurable disease.
  • No prior chemotherapeutic regimen for metastatic disease.
  • Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
  • Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
  • Signed written informed consent prior to study entry.

Exclusion Criteria:

Main exclusion criteria :

  • Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
  • Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
  • Peripheral neuropathy >Grade 1.
  • Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
  • Concurrent active cancer originating from a primary site other than colon or rectum.
  • Presence of any symptom suggesting brain metastasis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305188

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00305188    
Other Study ID Numbers: EFC5505
EUDRACT : 2005-002570-30
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Neurotoxicity syndromes
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neurotoxicity Syndromes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nervous System Diseases
Chemically-Induced Disorders
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex