BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Advanced Colorectal Carcinoma|
- Response rate of BMS-247550 in colon cancer [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||December 2004|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
IV administration of BMS-247550 once every 21 days
Other Name: ixabepilone, Ixempra®
- Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550.
- Determine the toxicity of this drug in these patients.
- Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.
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 are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Decatur Memorial Hospital Cancer Care Institute|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|LaGrange Memorial Hospital|
|LaGrange, Illinois, United States, 60525|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Lutheran General Cancer Care Center|
|Park Ridge, Illinois, United States, 60068|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46601|
|United States, Michigan|
|Lakeland Medical Center - St. Joseph|
|Saint Joseph, Michigan, United States, 49085|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|