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A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumours

Capecitabine and docetaxel are both active against a variety of solid tumours, while their toxicity profiles only partly overlap. This phase I study was performed to determine the maximum tolerated dose (MTD) and side-effects of the combination, and to establish whether there is any pharmacokinetic...

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Detalles Bibliográficos
Autores principales: Pronk, L C, Vasey, P, Sparreboom, A, Reigner, B, Planting, A S Th, Gordon, R J, Osterwalder, B, Verweij, J, Twelves, C
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2000
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2374547/
https://www.ncbi.nlm.nih.gov/pubmed/10883663
http://dx.doi.org/10.1054/bjoc.2000.1160
Descripción
Sumario:Capecitabine and docetaxel are both active against a variety of solid tumours, while their toxicity profiles only partly overlap. This phase I study was performed to determine the maximum tolerated dose (MTD) and side-effects of the combination, and to establish whether there is any pharmacokinetic interaction between the two compounds. Thirty-three patients were treated with capecitabine administered orally twice daily on days 1–14, and docetaxel given as a 1 h intravenous infusion on day 1. Treatment was repeated every 3 weeks. The dose of capecitabine ranged from 825 to 1250 mg m(–2)twice a day and of docetaxel from 75 to 100 mg m(–2). The dose-limiting toxicity (DLT) was asthenia grade 2–3 at a dose of 1000 mg m(–2)bid of capecitabine combined with docetaxel 100 mg m(–2). Neutropenia grade 3–4 was common (68% of courses), but complicated by fever in only 2.4% of courses. Other non-haematological toxicities were mild to moderate. There was no pharmacokinetic interaction between the two drugs. Tumour responses included two complete responses and three partial responses. Capecitabine 825 mg m(–2)twice a day plus docetaxel 100 mg m(–2)was tolerable, as was capecitabine 1250 mg m(–2)twice a day plus docetaxel 75 mg m(–2). © 2000 Cancer Research Campaign