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

Metastatic Breast Cancer Clinical Trial

Official title: Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons

Status Completed

Clinical Trial 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.

Clinical Trial Description

Eligible patient population:

• Stage 4 breast cancer

• Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)

• No limit on prior number of therapies to treat cancer

• Adequate organ function

• Life expectancy greater than 3 months

Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours

Evaluation on Study:

I. Efficacy evaluation:

• Baseline CT chest, abdomen and pelvis and bone scan within 4 weeks of starting therapy

• Evaluation of disease every 2 cycles of chemotherapy

• Ongoing toxicity evaluation using NCI CTC 3.

II. Neurological evaluation:

• Detailed neurologic exam using Neuropathy Assessment Instrument (represents a standard neurological exam)

• Serum NGF, IL 8,10, prior to starting therapy and prior to each cycle of ixabepilone

• DNA for assessment of TRK A and MDR1 polymorphisms

• Punch biopsy of skin prior to starting therapy and after every 2 cycles. Laboratory evaluation of peripheral nerve biopsies will be conducted at Rockefeller University under the direction of Dr. Carlson in Dr. Strickland's Lab. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT00627978
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: January 2011