A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
- 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
- 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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Angela Davies, MD
University of California, Davis
United States: Federal Government
|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|