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. 2000 Jun 2;83(1):22–29. doi: 10.1054/bjoc.2000.1160

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

L C Pronk 1, P Vasey 2, A Sparreboom 1, B Reigner 3, A S Th Planting 1, R J Gordon 3, B Osterwalder 3, J Verweij 1, C Twelves 2
PMCID: PMC2374547  PMID: 10883663

Abstract

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–2twice 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–2bid 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–2twice a day plus docetaxel 100 mg m–2was tolerable, as was capecitabine 1250 mg m–2twice a day plus docetaxel 75 mg m–2. © 2000 Cancer Research Campaign

Keywords: phase I, pharmacokinetics, capecitabine, docetaxel

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Selected References

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