A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV. - NA

Conditions: Patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV
at risk of cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin.
MedDRA version: 8Level: LLTClassification code 10034620

Registration Number: EUCTR2005-002570-30-DE

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

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

- 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.