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

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Colorectal Neoplasms

Treatments

Drug: Placebo

Drug: Xaliproden

Study type

Interventional

Funder types

Industry

Identifiers

NCT00603577

XALIP_C_02090

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.