Phase I Study of BMS-247550 in Patients With Refractory Neoplasms
OBJECTIVES: I. Determine the maximum tolerated dose, dose-limiting toxic effects, and
recommended phase II dose of BMS-247550 in patients with refractory neoplasms.
II. Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients.
III. Determine the occurrence of response in patients treated with this drug.
PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive BMS-247550 IV over 1
hour on days 1-5. Treatment continues every 3 weeks in the absence of disease progression
or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of BMS-247550 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined,
additional patients are accrued to receive BMS-247550 at the recommended phase II dose.
If neutropenia is identified as the DLT, a second dose escalation is performed to identify
the MTD of BMS-247550 with the addition of filgrastim (G-CSF) in cohorts as above. Patients
receive fixed-dose G-CSF 72 hours after final BMS-247550 dose, and continuing until blood
levels return to normal.
A total of 45 patients will be accrued for this study within 12-18 months.
Primary Purpose: Treatment
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|