Patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV
Conditions
Interventions
Product Name: Xaliproden hydrochloride
Product Code: SR57746A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Xaliproden hydrochloride
CAS Number: 90494-79-4
Current Sponsor code: SR57746A
Con
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically-proven metastatic cancer of the colon or rectum. - Metastatic disease not curable by surgery or amenable to radiation therapy with curative intent. - Male or female aged =18 years. - WHO Performance Status (PS) : 0 or 1. - At least one unidimensionally measurable lesion with a diameter =20 mm using conventional CT or MRI scans or =10 mm using spiral CT scans. - No prior chemotherapeutic regimen for metastatic disease. - Prior adjuvant chemotherapy for non-metastatic disease with 5-FU/LV, with 5- FU/levamizole, with irinotecan/5-FU/LV, with capecitabine is allowed. In case of prior adjuvant chemotherapy, the Disease-Free interval from end of the adjuvant therapy should be greater than 6 months. - Prior adjuvant chemotherapy with oxaliplatin/5-FU/LV is allowed provided the progression free interval from end of adjuvant therapy is greater than 12 months. - Serum creatinine =1.5 X the institution’s ULN. - Have adequate organ function and be medically stable. - Signed written informed consent (approved by the Ethics Committee) obtained prior to study-specific screening procedure. 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: - Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information. - Peripheral neuropathy >Grade 1 (as defined by the NCI CTCAE version 3.0). - Undetectable Sensory Action Potential (SAP) of both sural nerves as shown by the baseline nerve conduction studies (NCS). - Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy: Ca/Mg, carbamazepine, amitriptyline, gabapentin, phenytoin, gluthatione, alpha-lipoic acid, celecoxib, amifostine, venlaflaxine, vitamin B1 (thiamine), B6 (pyridoxine). - Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (NY Heart Association Classification III or IV), serious cardiac arrhythmia, diabetes, or active infection. - Presence of any symptom suggesting brain metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Neuroprotection: Reduction in the risk of occurrence of Grade 3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin.;Secondary Objective: 1- Main secondary objective: -Chemotherapy efficacy: Response Rate (RR) between the control arm A and the experimental arm B in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden. 2-Other secondary objectives: -Neuroprotection: • Duration of oxaliplatin-induced PSN (Grade 2, 3, 4). • Overall incidence of PSN during treatment by patient and by grade (Grades 1, 2, 3-4). • Time and Dose to onset of PSN (Grades 1, 2, 3-4). • Incidence of dose-reduction and dose-delay due to PSN. • Incidence of oxaliplatin treatment discontinuation due to PSN. • Change in Nerve Conduction Studies (NCS). -Safety profile (other than PSN) -Chemotherapy efficacy: • Progression Free Survival (PFS) • Overall survival (OS).;Primary end point(s): Primary efficacy endpoint is the probability of occurrence of Grade 3-4 PSN relative to the cumulative dose of oxaliplatin estimated using the Kaplan-Meier method and compared between the two treatment groups using a 2-sided logrank test with a type I error of 0.05. | — |
Countries
Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed