Phase I/II Trial of Amifostine, High-Dose Cisplatin and Docetaxel in Patients With Advanced Lung Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when combined with
amifostine and high dose cisplatin in patients with advanced non-small cell lung cancer. II.
Determine the response rate and survival of these patients treated with this regimen. III.
Determine the tolerability of this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of docetaxel. Patients receive
amifostine IV over 15 minutes, immediately followed by docetaxel IV over 1 hour, followed at
hour 2 by amifostine as above, immediately followed by high dose cisplatin IV over 30
minutes. Treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of patients receive escalating doses of docetaxel until the
maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Primary Purpose: Treatment
Joan H. Schiller, MD
University of Wisconsin, Madison
United States: Federal Government
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|