Clinical trial NCT00603577: Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (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 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (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


Eligibility 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 Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
* Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (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.

Primary outcomes:
measure: Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
timeFrame: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits
Secondary outcomes:
measure: FACT/GOG NTX-12 subscale
timeFrame: AT inclusion and subsequently monthly until month 12
measure: Hematological and biochemical testing
timeFrame: At inclusion, 3 & 6 months
measure: AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)
timeFrame: During the whole study period (including follow-up)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Québec
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Frankfurt
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Kallithea
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jean-Philippe Aussel
role: PRINCIPAL_INVESTIGATOR
References: