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Annals of Oncology 13:399-402, 2002
© 2002 European Society for Medical Oncology

Topotecan in combination with carboplatin: phase I trial evaluation of two treatment schedules

A. B. Simpson1,+, P. M. Calvert2, J. A. Sludden1, A. V. Boddy2, M. J. Griffin2, A. Schätzlein1, P. Wilson1, K. Fishwick2, A. Wheatley3, G. A. Ross3, A. H. Calvert2 and C. J. Twelves1,§

Cancer Research Campaign Departments of Medical Oncology, 1Glasgow and 2Newcastle-upon-Tyne; 3SmithKline Beecham, Harlow, Essex, UK

Received 21 March 2001; revised 23 August 2001. accepted 10 September 2001.

Background

Topotecan and cisplatin combinations have shown schedule-dependent toxicity, which may in part be due to cisplatin nephrotoxicity. As carboplatin is less nephrotoxic and increasingly replacing cisplatin in clinical practice, the aim of this study was to define the optimal sequence and dose for topotecan in combination with carboplatin.

Patients and methods

Two parallel phase I trials, with pharmacokinetic studies, were conducted administering carboplatin on day 1 with topotecan on days 1–5 (schedule A) or days 8–12 (schedule B), repeated every 3 weeks.

Results

Twenty-one patients were treated over two dose levels, carboplatin AUC 4 [glomerular filtration rate (GFR) calculated from 51Cr-EDTA clearance] with topotecan 0.5 or 0.75 mg/m2. At the first dose level, six patients were evaluable for each schedule. With schedule A, from 34 cycles, there were two dose reductions and 10 treatment delays due to myelosuppression. With schedule B from 25 cycles, there was one reduction and 10 delays. At dose level 2, both patients in schedule A had dose-limiting neutropenia. In contrast, there was no dose-limiting toxicity with schedule B in six patients, although the majority of cycles were delayed.

Conclusion

The combination of topotecan and carboplatin using these 3-weekly schedules lead to significant myelotoxicity with attendant dose reductions and delays; the optimal scheduling of these agents remains to be defined.

Key words: carboplatin, chemotherapy, topotecan


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