Phase I study of intermittent and chronomodulated oral therapy with capecitabine in patients with advanced and/or metastatic cancer

BMC Cancer
D SantiniG Tonini

Abstract

The combination of capecitabine and gemcitabine at Fixed Dose Rate (FDR) has been demonstrated to be well tolerated, with apparent efficacy in patients with advanced cancers. FDR gemcitabine infusion leads to enhanced intracellular accumulation of drug and possible augmented clinical effect. The goals of this phase I study were to determine the maximum-tolerated dose (MTD) of chronomodulated capecitabine in patients with advanced cancer and to describe the dose-limiting toxicities (DLT), the safety profile of this way of administration. Patients with advanced solid tumours who had failed to response to standard therapy or for whom no standard therapy was available were eligible for this study. Capecitabine was administered orally according to following schedule: 1/4 of dose at 8:00 a.m.; 1/4 of dose at 6:00 p.m. and 1/2 of dose at 11:00 p.m. each day for 14 consecutive days, followed by a 7-day rest period. All 27 patients enrolled onto the study were assessable for toxicity. The most common toxicities during the first two cycles of chemotherapy were fatigue, diarrhoea and hand foot syndrome (HFS). Only one out of the nine patients treated at capecitabine dose of 2,750 mg/m2 met protocol-specified DLT criteria (fatigue grade 4)...Continue Reading

References

Jun 1, 1992·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·UNKNOWN Nordic Gastrointestinal Tumor Adjuvant Therapy Group
Oct 1, 1988·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·H M Pinedo, G F Peters
Jul 1, 1996·Current Opinion in Oncology·F Lévi
Sep 17, 1998·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M MackeanJ Verweij
Aug 11, 2000·Critical Reviews in Oncology/hematology·J L MissetE Cvitkovic
Aug 16, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·A de GramontA Bonetti
Sep 28, 2000·The New England Journal of Medicine·L B SaltzL L Miller
Apr 5, 2001·Clinical Pharmacokinetics·B ReignerE Weidekamm
Jun 12, 2002·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Díaz-RubioJ Baselga
Sep 3, 2002·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·P Therasse
Sep 15, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·P ThirionUNKNOWN Meta-Analysis Group in Cancer
Nov 13, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hanna K SanoffRichard M Goldberg

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Citations

Oct 27, 2006·Expert Opinion on Emerging Drugs·Bruno VincenziGiuseppe Tonini
May 10, 2020·Pharmaceutical Research·Jeroen RoosendaalSerena Marchetti

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BETA
xenograft

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