Phase I clinical trial and pharmacokinetics of carboplatin (NSC 241240) by single monthly 30-minute infusion.

Abstract:

:Carboplatin (diammine [1,1-cyclobutanedicarboxylate(2-)-O,o']platinum) is a second generation platinum coordination complex. It has a spectrum of activity that is similar to that of cisplatin and is less nephrotoxic and emetogenic in experimental animals. Fifty-two 30-minute infusions of carboplatin were given to 20 evaluable patients with a variety of solid tumors. Maximum tolerated dose was 440 mg/m2. Thrombocytopenia (less than 100,000/mm3) occurred in six of seven patients; two patients experienced a leukocyte count less than 2000/mm3. Platelet and leukocyte count nadirs occurred on day 21. No nephrotoxicity was seen. Blood urea nitrogen, serum creatine levels, and creatinine clearances remained normal, and no consistent elevation of urinary beta 2-microglobulin, leucine aminopeptidase, or N-acetyl-beta-glucosaminidase occurred. Nausea and vomiting were mild to moderate. A single patient developed mild peripheral neuropathy. No auditory toxicity was noted. The recommended dose for Phase II studies is 400 mg/m2 every 28 days for good risk patients; heavily pretreated patients should receive 320 mg/m2.

journal_name

Cancer

journal_title

Cancer

authors

Koeller JM,Trump DL,Tutsch KD,Earhart RH,Davis TE,Tormey DC

doi

10.1002/1097-0142(19860115)57:2<222::aid-cncr28205

subject

Has Abstract

pub_date

1986-01-15 00:00:00

pages

222-5

issue

2

eissn

0008-543X

issn

1097-0142

journal_volume

57

pub_type

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