Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the
safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced
peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours
on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient
is benefitting. In addition patients will receive ALC or placebo, starting 1 week before
first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone.
Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be
determined by the incidence of all grades of peripheral neuropathy with the results of a
patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined
by the tumor response.