A multicenter, 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 - XENO
- Conditions
- Patient with oxaliplatin-induced peripheral sensory neuropathy after having completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colorectal tumorMedDRA version: 9.1Level: LLTClassification code 10040039Term: Sensory peripheral neuropathy
- Registration Number
- EUCTR2007-000945-36-GB
- Lead Sponsor
- sanofi-aventis groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 244
1/ Patient’s consent obtained, with Informed Consent Form signed and dated prior to protocol-specific procedures;
2/ Have had an oxaliplatin-containing chemotherapy regimen post complete surgical removal of the primary colon tumor, with the last infusion of oxaliplatin no more than 6 weeks before randomization; (If the fluropyrimidine alone [iv 5-FU/LV or capecitabine] is continued post discontinuation of oxaliplatin, the patient can be included and xaliproden given concomitantly, however reintroduction of oxaliplatin is not permitted);
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 <1.5xUNL; (c) HbA1c <7%; (d) neutrophils >1.5x109/L (e) platelets =50x109/L, (f) Serum D-dimer within normal limits. In case of positive D-dimer, the patient can be included provided that deep venous thrombo-embolism / pulmonary embolism have been ruled out by specific procedures (such as Doppler examination of lower limbs, spiral CT scan of lungs).
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
1/ Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
2/ Receiving any further anti-cancer treatment (except if the fluropyrimidine component alone [iv 5-FU/LV or capecitabine] is continued post discontinuation of oxaliplatin [as part of the adjuvant chemotherapy regimen]; however reintroduction of oxaliplatin is not permitted).
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method