Phase I/II Trial of the Epothilone B Analogue BMS 247550 (NSC 710428)/Cisplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
I. Determine the recommended phase II dose of BMS-247550 when administered with cisplatin in
patients with metastatic or recurrent squamous cell carcinoma of the head and neck. (Phase
I) II. Determine the toxic effects of this regimen in these patients. III. Determine the
response rate, time to progression, and survival of patients treated with this regimen.
(Phase II) IV. Determine the pharmacokinetics of this regimen in these patients. V.
Correlate selected markers from peripheral blood mononuclear cells and tumor samples with
toxicity and response in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study of BMS-247550.
Phase I: Patients receive BMS-247550 IV over 3 hours and cisplatin IV over 30-60 minutes on
day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 additional
patients receive treatment as above at the recommended phase II dose of BMS-247550.
Phase II: Patients receive treatment as in Phase I at the recommended phase II dose of
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Diane M. Hershock, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
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