Phase I Study of Intravenous BMS-214662 FTI (NSC# 710086) and Herceptin (NSC# 688097) Weekly in Patients With Advanced Malignancies
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when
combined with trastuzumab (Herceptin) in patients with advanced solid tumors.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
I. Determine the pharmacokinetics of this regimen in these patients. Ii. Determine, in a
preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of BMS-214662.
Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab
(Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 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 toxicity. Once the MTD is determined, additional patients
are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II
PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the highest dose level at which =< 1/6 subjects experience a study related dose-limiting toxicity (DLT) as assessed by CTC version 2.0
Fox Chase Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|