Patient with oxaliplatin-induced peripheral sensory neuropathy after having completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colorectal tumor MedDRA version: 9.1 Level: LLT Classification code 10040039 Term: Sensory peripheral neuropathy
Conditions
Interventions
Product Name: xaliproden hydrochloride
Product Code: SR57746A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: xaliproden
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
sanofi-aventis groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/ Patient’s consent obtained, with Informed Consent Form signed and dated prior to protocol-specific procedures; 2/ Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization; 3/ Have Grade = 1 PSN, as defined by the NCI-CTCAE version 3.0, 4/ Be at least 18 years of age; 5/ Have an ECOG Performance Status = 2; 6/ Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) =2 UNL; (b) serum creatinine 1.5x109/L (e) platelets =50x109/L, (f) Serum D-dimer within normal limits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1/ Pre-existing peripheral neuropathy prior to treatment with oxaliplatin 2/ Receiving any further anti-cancer treatment 3/ History of any recent (= 1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism 4/ Unstable cardiac disease. 5/ History of significant neurological or psychiatric disorders including dementia or seizures, 6/ Active uncontrolled infection 7/ Active disseminated intravascular coagulation 8/ Other serious underlying medical conditions which could impair the ability of the patient to participate in the study; 9/ 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. 10/ Concurrent treatment with any other experimental drugs. 11/ Pregnant or breast-feeding women; 12/ 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. 13/ 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 effects 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 effect of xaliproden on the time to complete recovery from PSN •To evaluate the safety profile of xaliproden ;Primary end point(s): Assessment of neurological sensory, as graded by the investigator using the NCI-CTCAE (version 3.0). | — |
Countries
France, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed