A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
OBJECTIVES:
- Determine the levels of hepatic impairment at which dose modifications of ixabepilone
are required in patients with advanced solid tumors or lymphomas and varying levels of
liver dysfunction.
- Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug
in these patients.
- Determine the toxic effects of this drug at varying levels of hepatic dysfunction in
these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at
least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24
for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
dose defining
Yes
Angela Davies, MD
Principal Investigator
University of California, Davis
United States: Federal Government
CDR0000258060
NCT00049400
October 2003
December 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |