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|
- 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.
|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)|