A Phase I trial of Cis-diammine-1,1-cyclobutane dicarboxylate platinum II (Carboplatin, CBDCA, JM-8) with a single dose every five week-schedule

Rudolf A. Joss, Shoshanna Kaplan, Aron Goldhirsch, Cristiana Sessa, Kurt W. Brunner, Franco Cavalli

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Carboplatin, a new platinum analogue, was administered intravenously on a schedule of a single dose every five weeks to 23 patients with advanced malignant solid tumors. Patients were treated at six dosage levels ranging from 200-550 mg/m2 every five weeks. Thrombocytopenia was dose-limiting. At 550 mg/m2 Carboplatin, the median platelet nadir was 65 000/mm3. Leukopenia was common, but usually of mild to moderate degree. Gastrointestinal upset was commonly seen at all dose levels, but 35% of the patients experienced no vomiting. No significant increase of the serum creatinine following Carboplatin was seen. In 16 patients serial determinations of the creatinine clearance were performed. The median base line creatinine clearance was 87 (50-155) ml/min and dropped to a median lowest creatinine clearance of 69 (23-171) ml/min on day four (p <0.05). The median creatinine clearance before the next Carboplatin treatment was 89 (42-155) ml/min. No significant proteinuria or electrolyte disturbances were noted. Carboplatin exhibited antitumor activity in ovarian, endometrial, thyroid and gastric carcinomas. The maximally tolerated dose appears to be 550 mg/m2 every five weeks. A starting dose of 450 mg/m2 seems to be appropriate for Phase II studies. In patients with impaired renal function and/or prior cis-Platin chemotherapy, Carboplatin at doses of 200-500

Original languageEnglish
Pages (from-to)297-304
Number of pages8
JournalInvestigational New Drugs
Volume2
Issue number3
DOIs
Publication statusPublished - Sep 1984

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Carboplatin
Platinum
Appointments and Schedules
Creatinine
Maximum Tolerated Dose
Leukopenia
Proteinuria
Thyroid Neoplasms
Thrombocytopenia
Electrolytes
Vomiting
1,1-cyclobutane dicarboxylate
Stomach
Blood Platelets
Kidney
Drug Therapy
Serum
Neoplasms

Keywords

  • 1-cyclobutane dicarboxylate platinum II
  • Carboplatin
  • CBDCA
  • Cis-diammine-1
  • JM-8
  • Phase I trial
  • platinum analogues

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

A Phase I trial of Cis-diammine-1,1-cyclobutane dicarboxylate platinum II (Carboplatin, CBDCA, JM-8) with a single dose every five week-schedule. / Joss, Rudolf A.; Kaplan, Shoshanna; Goldhirsch, Aron; Sessa, Cristiana; Brunner, Kurt W.; Cavalli, Franco.

In: Investigational New Drugs, Vol. 2, No. 3, 09.1984, p. 297-304.

Research output: Contribution to journalArticle

Joss, Rudolf A. ; Kaplan, Shoshanna ; Goldhirsch, Aron ; Sessa, Cristiana ; Brunner, Kurt W. ; Cavalli, Franco. / A Phase I trial of Cis-diammine-1,1-cyclobutane dicarboxylate platinum II (Carboplatin, CBDCA, JM-8) with a single dose every five week-schedule. In: Investigational New Drugs. 1984 ; Vol. 2, No. 3. pp. 297-304.
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