Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

Colorectal Neoplasms Clinical Trial

— XENON  

Official title:

A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00603577
• Other study ID #: XALIP_C_02090
• Status: Terminated
• Phase: Phase 3
• First received: January 17, 2008
• Last updated: January 19, 2010
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

• To assess the effect of xaliproden on patient-reported outcomes using the FACT/GOG NTX-12 subscale.

• To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months

• To assess the effects of xaliproden on the time to complete recovery from PSN

• To evaluate the safety profile of xaliproden

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;

• Have Grade = 1 PSN, as defined by the NCI-CTCAE version 3.0

• Have an ECOG Performance Status =2;

• Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) =2 ULN; (b) serum creatinine =1.5xUNL; (c)HbA1c =7%; (d) neutrophils =1.5x10^9/L ; (e) platelets =50x10^9/L; (f) Serum D-dimer within normal limits

Exclusion Criteria:

• Pre-existing peripheral neuropathy prior to treatment with oxaliplatin

• Receiving any further anti-cancer treatment

• History of any recent (=1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism

• Unstable cardiac disease

• History of significant neurological or psychiatric disorders including dementia or seizures,

• Active uncontrolled infection

• Active disseminated intravascular coagulation

• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;

• Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed

• Concurrent treatment with any other experimental drugs

• Pregnant or breast-feeding women;

• Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• placebo
placebo
• xaliproden
1.0 mg capsule or matching placebo. One capsule of investigational product (IP) daily for 6 months or until resolution of PSN (whichever comes first).

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Québec
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Frankfurt
Greece	Sanofi-Aventis Administrative Office	Kallithea
Italy	Sanofi-Aventis Administrative Office	Milan
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Greece,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological sensory assessment using the NCI-CTCAE (Version 3.0)		inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits	No
Secondary	FACT/GOG NTX-12 subscale		AT inclusion and subsequently monthly until month 12	No
Secondary	Hematological and biochemical testing		At inclusion, 3 & 6 months	No
Secondary	AE graded with NCI CTAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)		During the whole study period (including follow-up)	Yes