Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.