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

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ClinicalTrials.gov Identifier: NCT00305188
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 20, 2006
First Posted Date  ICMJE March 21, 2006
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
  • Main: response rate using RECIST criteria [ Time Frame: Q8W ]
  • Other: nerve conduction studies [ Time Frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug ]
  • Other: progression free survival and survival [ Time Frame: Q8W and study period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
  • Main:Response rate using RECIST criteria : Q8W
  • Other: Safety : Q2W ; nerve conduction studies : baseline, end of treatment with oxaliplatin, end of treatment with study drug ; progression free survival : Q8W ; survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Metastases
  • Colorectal Neoplasms
  • Colorectal Carcinoma
Intervention  ICMJE
  • Drug: Xaliproden (SR57746A)
    oral administration
  • Drug: Placebo
    oral administration
  • Drug: Oxaliplatin
    IV administration
  • Drug: 5-Fluorouracil
    IV administration
    Other Name: 5-FU
  • Drug: Leucovorin
    IV administration
    Other Name: LV
Study Arms  ICMJE
  • Experimental: Xaliproden (SR57746A)
    Interventions:
    • Drug: Xaliproden (SR57746A)
    • Drug: Oxaliplatin
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Oxaliplatin
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
879
Original Enrollment  ICMJE
 (submitted: March 20, 2006)
900
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   Germany,   Hungary,   Italy,   Poland,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT00305188
Other Study ID Numbers  ICMJE EFC5505
EUDRACT : 2005-002570-30
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP