Phase I Study of Cis-Diamminedicholoroplatinum in Combination With ICRF-187 in the Treatment of Advanced Malignancies
- 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
- To describe the toxicities of infusional dexrazoxane hydrochloride and cisplatin given
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
After completion of study treatment, patients are followed periodically.
Primary Purpose: Treatment
Stephen I. Shibata, MD
Beckman Research Institute
United States: Federal Government