Clinical Study

British Journal of Cancer (2005) 92, 445–448. doi:10.1038/sj.bjc.6602368 www.bjcancer.com
Published online 25 January 2005

A phase II study of raltitrexed and gemcitabine in patients with advanced pancreatic carcinoma

J J Arends1, H P Sleeboom2, M B L Leys3, D ten Bokkel Huinink4, R S de Jong5, J M Smit6, J W R Nortier1 and M E T Tesselaar1

  1. 1Department of Clinical Oncology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
  2. 2Departments of Internal Medicine, Leyenburg Hospital, PO Box 40551, 2504 LN The Hague, The Netherlands
  3. 3Medical Center Rijnmond, PO Box 9119, 3007 AC Rotterdam, The Netherlands
  4. 4Diakonessen Hospital, PO Box 80250 3508 TG Utrecht, The Netherlands
  5. 5Martini Hospital, PO Box 30033. 9700 RM Groningen
  6. 6Gelre Hospital, PO Box 9014, 7300 DS Apeldoorn, The Netherlands

Correspondence: MET Tesselaar, E-mail: m.e.t.tesselaar@lumc.nl

Received 27 August 2004; Revised 7 December 2004; Accepted 7 December 2004; Published online 25 January 2005.

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Abstract

Advanced adenocarcinoma of the pancreas has a very poor prognosis. The aim of this study was to assess the efficacy and tolerability of a combination of the chemotherapeutic agents gemcitabine and raltitrexed. Chemonaïve patients with advanced adenocarcinoma of the pancreas were treated with a combination of raltitrexed (3.5 mg m-2 on day 1 of a 21-day treatment cycle) and gemcitabine (800 mg m-2 intravenously (i.v.) on days 1 and 8 of a 21-day cycle). Between April 2000 and February 2003, 27 patients were enrolled onto the study. The mean duration of treatment was 11 weeks. Four of 27 patients experienced at least one episode of grade 3 or 4 neutropenia. One patient with grade 4 neutropenia died due to sepsis. Four of 27 patients experienced grade 4 diarrhoea. There was one partial remission (4%) and 12 patients experienced disease stabilisation (44%). The 6-month and 1-year survival rates were 37 and 11%, respectively. Symptomatic benefit occurred in seven (26%) patients. We conclude that a combination of raltitrexed and gemcitabine, using the schedule and doses in this study, cannot be recommended for patients with advanced pancreatic cancer.

Keywords:

gemcitabine, pancreatic cancer, raltitrexed, phase II