Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
NCT ID: NCT00305188
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
879 participants
INTERVENTIONAL
2005-12-31
2009-10-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Xaliproden (SR57746A)
Xaliproden (SR57746A)
oral administration
Oxaliplatin
IV administration
5-Fluorouracil
IV administration
Leucovorin
IV administration
Placebo
Placebo
oral administration
Oxaliplatin
IV administration
5-Fluorouracil
IV administration
Leucovorin
IV administration
Interventions
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Xaliproden (SR57746A)
oral administration
Placebo
oral administration
Oxaliplatin
IV administration
5-Fluorouracil
IV administration
Leucovorin
IV administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, , Australia
Sanofi-Aventis Administrative Office
São 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
Milan, , Italy
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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References
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Liu J, Wang X, Sahin IH, Imanirad I, Felder SI, Kim RD, Xie H. Tumor Response-speed Heterogeneity as a Novel Prognostic Factor in Patients With Metastatic Colorectal Cancer. Am J Clin Oncol. 2023 Feb 1;46(2):50-57. doi: 10.1097/COC.0000000000000972. Epub 2022 Dec 26.
Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
Other Identifiers
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EUDRACT : 2005-002570-30
Identifier Type: -
Identifier Source: secondary_id
EFC5505
Identifier Type: -
Identifier Source: org_study_id
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