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
PRIMARY OBJECTIVES:
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
dosing schedules.
SECONDARY OBJECTIVES:
I. To measure surviving expression and correlate with the therapeutic responsiveness to
BMS-247550.
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
treatment arms.
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.
Interventional
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
No
Barbara Burtness
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-02970
NCT00033618
November 2002
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |