Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of BMS-188797 in Patients With Advanced Malignancies
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-188797 in treating patients who
have advanced solid tumors that have not responded to previous treatment.
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose
limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies.
II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any
antitumor activity of this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-188797 IV over 1 hour.
Treatment continues every 21 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until
toxicities resolve, and then at the investigator's discretion.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study over 12-18
months.
;
Primary Purpose: Treatment
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