NCT00272051

Brief Summary

Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

January 3, 2006

Last Update Submit

September 11, 2006

Conditions

MetastasesColorectal NeoplasmsColorectal Carcinoma

Keywords

Neurotoxicity syndromesParesthesiaOxaliplatinXaliproden

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W

Secondary Outcomes (1)

  • Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival

Interventions

SR57746ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proven adenocarcinoma of the colon or the rectum
  • age \> 18 years
  • WHO performance status : 0,1,2
  • Signed written informed consent prior to study entry
  • Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)
  • Measurable disease
  • No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)
  • Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study

You may not qualify if:

  • Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy
  • Prior therapy with Oxaliplatin
  • History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency
  • History of intolerance to appropriate antiemetics
  • Concurrent active cancer originating from a primary site other than colon or rectum
  • Presence of any symptom suggesting brain metastasis
  • Known peripheral neuropathy
  • Interstitial pneumonia or extensive and symptomatic fibrosis of the lung
  • Allergy to Xaliproden/excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 36606664DERIVED

  • 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.

    PMID: 31378656DERIVED

  • 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.

    PMID: 30679026DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisColorectal NeoplasmsNeurotoxicity SyndromesParesthesia

Interventions

xaliproden

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNervous System DiseasesPoisoningChemically-Induced DisordersSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gérard SAID, MD

    Hôpital de Bicêtre - Le Kremlin-Bicêtre - France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

July 1, 2002

Study Completion

May 1, 2004

Last Updated

September 13, 2006

Record last verified: 2006-09