Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons

Summary

Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxicity * Exploratory studies: * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons. * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.

Timeline

Start

2007-11

Primary completion

2011-01

Completion

2011-01

Drugs

Indications