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
OBJECTIVES:
- 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
patients.
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
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Maha Hadi A. Hussain, MD
Study Chair
University of Michigan Cancer Center
United States: Federal Government
CDR0000068629
NCT00016393
June 2001
April 2006
Name | Location |
---|---|
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 |