Lymphoma Clinical Trial
Official title:
A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in
treating patients with advanced solid tumors or lymphomas and 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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