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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Suburban Hospital
Bethesda, Maryland, United States
Oncology Care Associates
Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
NCI - Center for Cancer Research
Bethesda, Maryland, United States
Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
Ixabepilone toxicity as measured by lab studies at baseline and after every course
Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2.
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
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