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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00603577
• Date of registration: 17/01/2008
• Primary sponsor: Sanofi-Aventis
• Public title: Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens XENON
• Scientific 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
• Date of first enrolment: January 2008
• Target sample size: 102
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00603577
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

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

Contacts

• Name: Jean-Philippe Aussel
• Affiliation: Sanofi-Aventis

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colorectal Neoplasms

Intervention(s)

Drug: placebo

Drug: xaliproden

Primary Outcome(s)

Neurological sensory assessment using the NCI-CTCAE (Version 3.0) [Time Frame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits]

Secondary Outcome(s)

AE graded with NCI CTAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1) [Time Frame: During the whole study period (including follow-up)]

FACT/GOG NTX-12 subscale [Time Frame: AT inclusion and subsequently monthly until month 12]

Hematological and biochemical testing [Time Frame: At inclusion, 3 & 6 months]

Secondary ID(s)

XALIP_C_02090

Source(s) of Monetary Support

Please refer to primary and secondary sponsors