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A phase I trial of continuous infusion cisplatin
Author(s) -
Posner Marshall R.,
Ferrari Laura,
Belliveau James F.,
Cummings Francis J.,
Wiemann Michael C.,
O'Rourke Anne,
Weitberg Alan B.,
Calabresi Paul
Publication year - 1987
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19870101)59:1<15::aid-cncr2820590107>3.0.co;2-q
Subject(s) - medicine , nausea , toxicity , leukopenia , cisplatin , vomiting , bolus (digestion) , nephrotoxicity , concomitant , anesthesia , urology , chemotherapy , pharmacokinetics , surgery
Treatment with continuous infusions of cisplatin results in increased filterable drug exposures as measured by the area under the curve (AUC) of nonprotein‐bound plasma platinum levels. To determine the dose‐limiting toxicity and optimal method of administration, 24 patients were treated with continuous infusions of cisplatin at a dose rate of 25 mg/M 2 /day in a limited Phase I trial. A total of 47 courses were given. Nine patients received 13 courses of 4 days duration, 19 received 29 courses of 5 days duration, and five received courses of 6 or 7 days duration. Dose‐limiting toxicity was found to be leukopenia: 42% of patients receiving the 5‐day treatment developed a nadir count of less than 3000 cells/mm 3 . Nausea and vomiting were easily controlled. Minimal nephrotoxicity occurred in five patients and was associated with daily volume expansion with 2 l of 0.9% NaCl solution in four patients. All other patients were given 3 l of daily volume expansion during treatment. Responses were seen in 6 of 22 evaluable patients (27%). It is concluded that continuous infusion cisplatin at a dose rate of 25 mg/M 2 /day can be given safely for 5 days as a single agent if concomitant volume expansion with at least 3 l of 0.9% NaCl solution is given daily. Phase III comparative trials with a conventional bolus and newer high‐dose regimens for response and toxicity are indicated. Cancer 59:15–18, 1987.