NCT00305188|CompletedPhase 3

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

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC5505EUDRACT : 2005-002570-30

Study Type

interventional

Target

879

Locations

13 countries

Sites

Timeline

RegisteredMar 2006

StartedDec 2005

CompletionOct 2009

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).

Trial Health

On Track

Trial Health Score

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

Enrollment

879

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2005

Typical duration for phase_3

Geographic Reach

13 countries

13 active sites

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

3.8 years study duration

Study Start

First participant enrolled

December 1, 2005

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

Last Updated

May 4, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

March 20, 2006

Last Update Submit

April 6, 2016

Conditions

Metastases Colorectal Neoplasms Colorectal Carcinoma

Keywords

Neurotoxicity syndromesParesthesiaOxaliplatinXaliproden

Outcome Measures

Primary Outcomes (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 Outcomes (3)

Main: response rate using RECIST criteria
Q8W
Other: nerve conduction studies
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Q8W and study period

Study Arms (2)

Xaliproden (SR57746A)

EXPERIMENTAL

Drug: Xaliproden (SR57746A)Drug: OxaliplatinDrug: 5-FluorouracilDrug: Leucovorin

Placebo

PLACEBO COMPARATOR

Drug: PlaceboDrug: OxaliplatinDrug: 5-FluorouracilDrug: Leucovorin

Interventions

Xaliproden (SR57746A)DRUG

oral administration

Xaliproden (SR57746A)

PlaceboDRUG

oral administration

Placebo

OxaliplatinDRUG

IV administration

PlaceboXaliproden (SR57746A)

5-FluorouracilDRUG

IV administration

Also known as: 5-FU

PlaceboXaliproden (SR57746A)

LeucovorinDRUG

IV administration

Also known as: LV

PlaceboXaliproden (SR57746A)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.