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History of Changes for Study: NCT00305188
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Latest version (submitted April 6, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 20, 2006 None (earliest Version on record)
2 September 8, 2006 Study Status
3 September 18, 2006 Contacts/Locations and Study Status
4 September 19, 2006 Contacts/Locations and Study Status
5 October 20, 2006 Study Status and Study Identification
6 April 2, 2007 Study Status
7 August 21, 2007 Study Status, Contacts/Locations and Study Design
8 December 31, 2007 Study Status and Sponsor/Collaborators
9 April 25, 2008 Study Status and Contacts/Locations
10 June 2, 2008 Study Status
11 August 29, 2008 Outcome Measures, Arms and Interventions, Study Design and Study Status
12 January 15, 2009 Recruitment Status, Study Status, Contacts/Locations and Study Identification
13 November 10, 2009 Recruitment Status, Study Status, Contacts/Locations, References and Study Identification
14 December 16, 2010 Study Design, Study Status, Contacts/Locations and Sponsor/Collaborators
15 April 6, 2016 Arms and Interventions, Study Status, Sponsor/Collaborators and Study Identification
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Study NCT00305188
Submitted Date:  March 20, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: EFC 5505
Brief Title: Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
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
Secondary IDs: SR57746A
Open or close this module Study Status
Record Verification: March 2006
Overall Status: Recruiting
Study Start: December 2005
Primary Completion:
Study Completion:
First Submitted: March 20, 2006
First Submitted that
Met QC Criteria:
March 20, 2006
First Posted: March 21, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 20, 2006
Last Update Posted: March 21, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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).

Detailed Description:
Open or close this module Conditions
Conditions: Metastases
Colorectal Neoplasms
Colorectal Carcinoma
Keywords: Neurotoxicity syndromes
Paresthesia
Oxaliplatin
Xaliproden
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 900
Open or close this module Arms and Interventions
Intervention Details:
Drug: SR57746A
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W during treatment, Q4W to Q12W during post-treatment follow-up.
Secondary Outcome Measures:
1. Main:Response rate using RECIST criteria : Q8W
2. Other: Safety : Q2W ; nerve conduction studies : baseline, end of treatment with oxaliplatin, end of treatment with study drug ; progression free survival : Q8W ; survival.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Public Registry ICD
Email: GV-Contact-us@sanofi-aventis.com
Locations: United States, Pennsylvania
Sanofi-Aventis
[Recruiting]
Malvern, Pennsylvania, United States, 19355
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Argentina
Sanofi-Aventis
[Recruiting]
Buenos Aires, Argentina, 1642
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Austria
Sanofi-Aventis
[Recruiting]
Vienna, Austria, DCA 1220
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Brazil
Sanofi-Aventis
[Recruiting]
Sao Paulo, Brazil, CEP 05677-000
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Chile
Sanofi-Aventis
[Recruiting]
Santiago, Chile
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Germany
Sanofi-Aventis
[Recruiting]
Berlin, Germany, D-10785
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Hungary
Sanofi-Aventis
[Recruiting]
Budapest, Hungary, H-1325
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Italy
Sanofi-Aventis
[Recruiting]
Milano, Italy, 20 158
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Sanofi-Aventis
[Recruiting]
Milano, Italy, 20158
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Poland
Sanofi-Aventis
[Recruiting]
Warszawa, Poland, 02-672
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Portugal
Sanofi-Aventis
[Recruiting]
Porto Salvo, Portugal, 2740-244
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Spain
Sanofi-Aventis
[Recruiting]
Barcelona, Spain, 08019
Contact:Contact: GV-Contact-us@sanofi-aventis.com
United Kingdom, Surrey
Sanofi-Aventis
[Recruiting]
Guildford, Surrey, United Kingdom, GU1 4YS
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Related Info
Available IPD/Information:

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