Ignite Creation Date:
2024-05-05 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00627978
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2008-02-22
Brief Title:
Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
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
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgm2 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 810 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 Stricklands Lab
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 mgm2 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 810 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 Stricklands Lab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None