The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
PRIMARY OBJECTIVES: I. To compare ixabepilone-induced peripheral neuropathy (sensory) as
measured by EORTC QLQ-CIPN20 sensory subscale between CaMg and placebo arms. SECONDARY
OBJECTIVES: I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+
peripheral neuropathy between CaMg and placebo arms. II. To compare the times to onset of
CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.
III. To compare the proportion of patients requiring ixabepilone dose reductions and/or
stopping ixabepilone secondary to peripheral neuropathy (sensory) between CaMg and placebo
arms. IV. To assess the toxicity of CaMg in this situation. V. To document the incidence and
severity of the acute pain syndrome (APS, commonly known as arthralgias/myalgias) induced by
ixabepilone. VI. To evaluate whether CaMg will decrease the acute pain syndrome (APS). VII.
To evaluate the incidence and characteristics of, and change in, ixabepilone-APS over
several cycles. VIII. To evaluate the association between the ixabepilone-APS and eventual
chemotherapy-induced neuropathy. OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes
immediately before and after ixabepilone treatment. ARM II: Patients receive calcium
placebo IV over 30 minutes immediately before and after ixabepilone treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Comparison of chemotherapy-induced peripheral neuropathy between CaMg and placebo arms, as measured by the sensory subscale of EORTC QLQ-CIPN20
During the first 18 weeks of ixabepilone-based therapy
Charles Loprinzi, M.D.
United States: Institutional Review Board
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