Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of BMS-247550 in Patients With Refractory Neoplasms
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have cancers that have not responded to previous therapy.
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. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 12-18 months. ;
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