A Randomized Phase II Study of BMS-247550 (NSC #710428) Given Daily x 5 Days Every 3 Weeks or Weekly in Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
I. To determine the response rate and toxicity of BMS-247550 given in two dosing schedules
in taxane-naïve and taxane-exposed patients.
II. To provide information about the response rate and toxicity of BMS-247550 given in two
I. To measure surviving expression and correlate with the therapeutic responsiveness to
II. To determine the changes in tumor vascular density and endothelial cell apoptosis in
response to therapy and the correlation of these changes to outcome.
OUTLINE: This is a randomized study. Patients are stratified according to prior taxane
therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2
Arm I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
In both arms, patients achieving complete response (CR) receive 2 additional courses past CR
if a minimum of 6 courses have been administered.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate, assessed using RECIST criteria
95% confidence interval will be computed.
Up to 5 years
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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