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Annals of Oncology 14:1776-1782, 2003
© 2003 European Society for Medical Oncology

Original Paper

Phase I and pharmacological study of an oxaliplatin and carboplatin combination in advanced malignancies

C. Mita1,+, E. Chatelut1, M. Bekradda3, P. Soulié4, P. Canal1, J.-L. Misset2, E. Cvitkovic2,3 and R. Bugat1,§

1 Institut Claudius Regaud, and Université Paul Sabatier, Toulouse; 2 Department of Medical Oncology, Hôpital Paul Brousse, Villejuif; 3 CAC, Kremlin-Bicêtre; 4 Centre René Huguenin, Saint-Cloud, France

Received 2 April 2003; revised 5 June 2003; accepted 11 August 2003

Background:

Phase I and pharmacokinetic study to determine the maximal tolerated dose and the recommended dose, as well as the optimal sequence of a carboplatin/oxaliplatin combination delivered every 3 weeks.

Patients and methods:

Patients received either carboplatin [area under the curve (AUC)-based individually calculated dose (starting dose AUC 4 mg·min/ml), 1 h intravenous (i.v.) infusion] followed by oxaliplatin (110 mg/m2, 2 h i.v. infusion), every 3 weeks, or the reverse sequence.

Results:

Sixteen patients were included and only one dose level was assessed. In group A, 10 patients received 23 cycles of carboplatin followed by oxaliplatin. In group B, 6 patients received 20 cycles with the reverse sequence. Delayed recovery from hematological toxicities was treatment-limiting, with mainly moderate thrombocytopenia and neutropenia as dose-limiting toxicities for group A (5 of 10 patients for each) and thrombocytopenia for group B (3 of 6 patients). No febrile neutropenia or grade 3/4 non-hematological toxicity occurred. Pharmacokinetic analysis showed similar mean total platinum AUCs for the two groups: 37.2 ± 13.7 and 33.6 ± 9.9 mg·h/l, respectively. One complete response and two partial responses (World Health Organization–International Union Against Cancer criteria, response rate 18.8%) were seen in ovarian, Fallopian and neuroendocrine carcinomas, respectively.

Conclusions:

This platinum combination appears feasible and active at the dose of AUC 4 mg·min/ml for carboplatin (Chatelut formula) and oxaliplatin 110 mg/m2; however, it does not allow a significant increase in platinum dose-intensity delivery.

Key words: carboplatin, oxaliplatin, pharmacokinetics, phase I study


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