Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
- Registration Number
- NCT00627978
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ixabepilone ixabepilone Participants are treated with Ixabepilone.
- Primary Outcome Measures
Name Time Method Axons With Abnormal Morphology Baseline and Over 7 cycles of treatment, approximately 21 weeks Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Weill Medical College of Cornell University
🇺🇸New York, New York, United States