Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma|
- Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course [ Designated as safety issue: No ]
- Ixabepilone toxicity as measured by lab studies at baseline and after every course [ Designated as safety issue: Yes ]
- Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2. [ Designated as safety issue: No ]
- Neurotoxicity assessment as measured by Semmes-Weinstein monofilament, sharpened Rombrog, one-legged stance, Jebsen Test of hand function, the grooved pef board , and subjective questionnaires at baseline and prior to every other course [ Designated as safety issue: Yes ]
|Study Start Date:||May 2002|
|Study Completion Date:||July 2007|
- Determine any antitumor activity of ixabepilone, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no).
Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks.
Patients removed for unacceptable toxicty are followed periodically.
PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045097
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Oncology Care Associates|
|Bethesda, Maryland, United States, 20817|
|Bethesda, Maryland, United States, 20814|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Sandra M. Swain, MD||National Cancer Institute (NCI)|