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Annals of Oncology 2:217-221, 1991
© 1991 European Society for Medical Oncology

research-article

Original articles: Teniposide and cisplatin given by intraperitoneal administration: Preclinical and phase I/pharmacokinetic studies

E. Chatelut1, M. de Forni1,2, P. Canal1,4, C. Chevreau1, H. Roche1, Y. Plusquellec2,4, N. P. Johnson3, G. Houin1,2,4 and R. Bugat1,2

1Unité de Pharmacologie et de Pharmacocinetique Cliniques, Centre Claudius Regaud Toulouse France
2Université Paul Sabatier Toulouse France
3CNRS U201 Toulouse, France
4Centre Interdisciplinaire d'Etudes Pharmacocinéliques de Toulouse (CINET) Toulouse, France

Correspondence to: P.Canal, M.D., Centre Claudius Regaud, 20-24 Rue du Pont Saint-Pierre, 31052 Toulouse Cedex, France

Cisplatin and teniposide given by intraperitoneal (IP) route exert a synergistic therapeutic effect against ascitic P388 leukemia in mice. As single agents, they display different dose-limiting toxicities and favourable pharmacokinetic characteristics in IP phase I trials. We administered cisplatin (fixed dose: 200 mg/m2) and teniposide (escalating doses) by IP route without dwell-time to investigate the toxicity, pharmacokinetics and clinical activity of this 2-drug combination. Nine patients received a total of 14 courses. Myelosuppression, nausea and vomiting were the most frequent toxicities. Leukopenia was the dose-limiting toxicity. The maximum tolerated dose of teniposide was 100 mg/m2 when administered with a fixed dose of 200 mg/m2 cisplatin. Pharmacokinetic analysis showed that the main parameters of both cisplatin and teniposide in the peritoneum and in the plasma were not modified when the drugs were combined. It appears that a pharmacodynamic interaction exists between cisplatin and teniposide which results in increased hematologic toxicity. Although an objective response has been observed in one patient with refractory ovarian cancer, such association should not be applicable for further clinical development due to marked toxicity and the low dose of teniposide recommended.


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