Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
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|ClinicalTrials.gov Identifier: NCT00627978|
Recruitment Status : Completed
First Posted : March 4, 2008
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
- Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
- Detailed characterization of peripheral neuropathy in patients who receive ixabepilone
- Clinical benefit rate
- Time to progression ( TTP)
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: ixabepilone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2007|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Participants are treated with Ixabepilone.
ixabepilone 40 mg/m2 Q3w over 3 hours
|No Intervention: Control|
- Axons With Abnormal Morphology [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627978
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Linda Vahdat, MD||Weill Medical College of Cornell University|