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

J. M. Koeller, D. L. Trump, K. D. Tutsch, R. H. Earhart, T. E. Davis, D. C. Tormey

Research output: Contribution to journalArticle

82 Citations (Scopus)

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 (<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 β2-microglobulin, leucine aminopeptidase, or N-acetyl-β-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 in 400 mg/m2 every 28 days for good risk patients; heavily pretreated patients should receive 320 mg/m2.

Original languageEnglish (US)
Pages (from-to)222-225
Number of pages4
JournalCancer
Volume57
Issue number2
DOIs
StatePublished - 1986
Externally publishedYes

Fingerprint

Clinical Trials, Phase I
Carboplatin
Pharmacokinetics
Platinum
Leukocyte Count
CD13 Antigens
Leucyl Aminopeptidase
Hexosaminidases
Maximum Tolerated Dose
Creatine
Blood Urea Nitrogen
Coordination Complexes
Peripheral Nervous System Diseases
Platelet Count
Thrombocytopenia
Nausea
Cisplatin
Vomiting
Creatinine
Serum

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase I clinical trial and pharmacokinetics of carboplatin (NSC 241240) by single monthly 30-minute infusion. / Koeller, J. M.; Trump, D. L.; Tutsch, K. D.; Earhart, R. H.; Davis, T. E.; Tormey, D. C.

In: Cancer, Vol. 57, No. 2, 1986, p. 222-225.

Research output: Contribution to journalArticle

Koeller, J. M. ; Trump, D. L. ; Tutsch, K. D. ; Earhart, R. H. ; Davis, T. E. ; Tormey, D. C. / Phase I clinical trial and pharmacokinetics of carboplatin (NSC 241240) by single monthly 30-minute infusion. In: Cancer. 1986 ; Vol. 57, No. 2. pp. 222-225.
@article{ab165b86ea87443bbb5d0c39d1f76b19,
title = "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 (<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 β2-microglobulin, leucine aminopeptidase, or N-acetyl-β-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 in 400 mg/m2 every 28 days for good risk patients; heavily pretreated patients should receive 320 mg/m2.",
author = "Koeller, {J. M.} and Trump, {D. L.} and Tutsch, {K. D.} and Earhart, {R. H.} and Davis, {T. E.} and Tormey, {D. C.}",
year = "1986",
doi = "10.1002/1097-0142(19860115)57:2<222::AID-CNCR2820570206>3.0.CO;2-X",
language = "English (US)",
volume = "57",
pages = "222--225",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "2",

}

TY - JOUR

T1 - Phase I clinical trial and pharmacokinetics of carboplatin (NSC 241240) by single monthly 30-minute infusion

AU - Koeller, J. M.

AU - Trump, D. L.

AU - Tutsch, K. D.

AU - Earhart, R. H.

AU - Davis, T. E.

AU - Tormey, D. C.

PY - 1986

Y1 - 1986

N2 - 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 (<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 β2-microglobulin, leucine aminopeptidase, or N-acetyl-β-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 in 400 mg/m2 every 28 days for good risk patients; heavily pretreated patients should receive 320 mg/m2.

AB - 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 (<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 β2-microglobulin, leucine aminopeptidase, or N-acetyl-β-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 in 400 mg/m2 every 28 days for good risk patients; heavily pretreated patients should receive 320 mg/m2.

UR - http://www.scopus.com/inward/record.url?scp=0022643991&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0022643991&partnerID=8YFLogxK

U2 - 10.1002/1097-0142(19860115)57:2<222::AID-CNCR2820570206>3.0.CO;2-X

DO - 10.1002/1097-0142(19860115)57:2<222::AID-CNCR2820570206>3.0.CO;2-X

M3 - Article

C2 - 3510700

AN - SCOPUS:0022643991

VL - 57

SP - 222

EP - 225

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 2

ER -