A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer
- Determine the prostate-specific antigen response to BMS-247550 in patients with
hormone-refractory prostate cancer.
- Determine the overall survival and progression-free survival rate in patients treated
with this drug.
- Determine the objective response rate (confirmed and unconfirmed complete and partial
responses) in those patients with measurable disease treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity. Patients achieving a complete
response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9
Masking: Open Label, Primary Purpose: Treatment
Maha Hadi A. Hussain, MD
University of Michigan Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|CCOP - Atlanta Regional||Atlanta, Georgia 30342-1701|
|Harrington Cancer Center||Amarillo, Texas 79106|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)||Hines, Illinois 60141|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Veterans Affairs Medical Center - Wichita||Wichita, Kansas 67218|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|Louisiana State University Health Sciences Center - Shreveport||Shreveport, Louisiana 71130-3932|
|Veterans Affairs Medical Center - Detroit||Detroit, Michigan 48201-1932|
|Veterans Affairs Medical Center - Portland||Portland, Oregon 97207|
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|Veterans Affairs Medical Center - San Antonio (Murphy)||San Antonio, Texas 78284|
|Veterans Affairs Medical Center - Seattle||Seattle, Washington 98108|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Oregon Cancer Institute||Portland, Oregon 97201-3098|
|Danville Radiation Therapy Center||Memphis, Tennessee 38104|
|Veterans Affairs Medical Center - Amarillo||Amarillo, Texas 79106|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|Swedish Cancer Institute at Swedish Medical Center - First Hill Campus||Seattle, Washington 98104|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|