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

Summary

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

Timeline

Start

2008-01

Primary completion

2009-11

Completion

2009-11

Outcome

Outcome not reported

Stopped: “development of product discontinued”

Drugs

Indications