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

L. Pronk,P. Vasey,A. Sparreboom,B. Reigner,B. Reigner,A. Planting,R. Gordon,R. Gordon,B. Osterwalder,B. Osterwalder,J. Verweij,C. Twelves

Published 2000 in British Journal of Cancer

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−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

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