Phase I Study of Cis-Diamminedicholoroplatinum in Combination With ICRF-187 in the Treatment of Advanced Malignancies
OBJECTIVES:
- To establish the maximum tolerated dose of a 96-hour continuous infusion of dexrazoxane
hydrochloride and a single-dose, one-hour infusion of cisplatin in patients with
advanced solid tumors.
- To determine the pharmacokinetics of dexrazoxane hydrochloride and cisplatin when given
concurrently.
- To describe the toxicities of infusional dexrazoxane hydrochloride and cisplatin given
in combination.
OUTLINE: Patients receive dexrazoxane hydrochloride IV continuously over 96 hours beginning
on day 1 and cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity.
Blood is collected periodically during course one for pharmacokinetic studies. DNA isolated
from the samples is also analyzed for oxidative DNA damage by gas chromatography/mass
spectrometry.
After completion of study treatment, patients are followed periodically.
Interventional
Primary Purpose: Treatment
Toxicity
Yes
Stephen I. Shibata, MD
Study Chair
Beckman Research Institute
United States: Federal Government
CDR0000570420
NCT00550901
February 2001
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