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Annals of Oncology Advance Access originally published online on November 10, 2005
Annals of Oncology 2006 17(1):50-56; doi:10.1093/annonc/mdj031
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© 2005 European Society for Medical Oncology

A phase I dose escalation study of continuous oral capecitabine in combination with oxaliplatin and pelvic radiation (XELOX-RT) in patients with locally advanced rectal cancer

R. Glynne-Jones1,*, D. Sebag-Montefiore2, T. S. Maughan3, S. J. Falk4 and A. C. McDonald5

1 Mount Vernon Cancer Centre, Northwood, London; 2 Leeds Cancer Centre, Leeds; 3 Velindre Cancer Centre, Whitchurch; 4 The Bristol Haematology & Oncology Centre, Bristol; 5 Beatson Oncology Centre, Glasgow, UK

* Correspondence to: Dr R. Glynne-Jones, Mount Vernon Cancer Centre, Northwood, London HA6 2RN, UK. Tel: +44-1923-844012; Fax: +44-1923-844138; E-mail: rob.glynne-jones{at}whht.nhs.uk

Purpose: To determine the maximum tolerated dose (MTD) of continuous oral capecitabine plus oxaliplatin and pre-operative pelvic radiotherapy (XELOX-RT).

Patients and methods: Patients with clinically unresectable rectal cancer or for whom resection with histologically clear (R0) surgical margins was unlikely received continuous capecitabine (500–825 mg/m2 twice daily, 7 days/week), oxaliplatin 2-h intravenous infusion (130 mg/m2 days 1 and 29) and pelvic radiotherapy (Monday–Friday for 5 weeks, total dose 45 Gy in 25 daily 1.8 Gy fractions). The MTD was the capecitabine dose causing dose-limiting toxicities (DLTs; treatment-related grade 3/4 toxicities) in one-third or more of patients treated per dose level.

Results: Eighteen patients received three dose levels. The MTD was capecitabine 825 mg/m2 twice daily: DLTs occurred in two of six patients (grade 3 diarrhoea, rectal pain with local skin reaction). No DLTs occurred in six patients receiving capecitabine 650 mg/m2 twice daily. Grade 3/4 toxicity was rare, with minimal myelosuppression. Although predominantly a dose-finding study, XELOX-RT showed promising activity. Fourteen patients had histologically confirmed R0 resections and five had a pathological complete response.

Conclusions: The recommended dose for further study is capecitabine 650 mg/m2 twice daily with oxaliplatin and radiotherapy. XELOX-RT showed promising antitumour activity. Further evaluation is underway.

Key words: Capecitabine, chemoradiation, locally advanced rectal cancer, oxaliplatin


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