Skip Navigation

This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (12)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Mackay, H. J.
Right arrow Articles by Cunningham, D.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Mackay, H. J.
Right arrow Articles by Cunningham, D.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Annals of Oncology 14:1264-1269, 2003
© 2003 European Society for Medical Oncology

Original Paper

A phase I/II study of oral uracil/tegafur (UFT), leucovorin and irinotecan in patients with advanced colorectal cancer

H. J. Mackay1, M. Hill2, C. Twelves1,4,+, R. Glasspool1, T. Price2, S. Campbell1, A. Massey2, M. A. Macham1, M. Uzzel2, S. M. Bailey3, C. Martin3 and D. Cunningham2

1 Cancer Research UK, Department of Medical Oncology, Beatson Oncology Centre, Western Infirmary, Glasgow; 2 Royal Marsden NHS Trust, Gastrointestinal Unit, London and Surrey; 3 Bristol-Myers Squibb Oncology, London, UK 4 University of Leeds and Tom Connors Cancer Research Centre, University of Bradford, Bradford, UK

Received 4 November 2002; revised 24 March 2003; accepted 15 April 2003

Background:

The aim of this study was to determine the maximum tolerated dose (MTD), toxicity profile and response rate of the oral 5-fluorouracil prodrug UFT (tegafur/uracil) and leucovorin (LV) in combination with irinotecan in patients with advanced or metastatic colorectal cancer.

Patients and methods:

Patients with histologically proven advanced or metastatic colorectal adenocarcinoma received first-line chemotherapy comprising UFT 250 mg/m2/day and LV 90 mg/day given on days 1 to 14, with escalating doses of irinotecan (200–300 mg/m2) administered intravenously on day 1 of a three-weekly cycle. Eligibility criteria were standard. The MTD was defined as the dose at which >33% of six patients experienced a dose-limiting toxicity (DLT) during cycle 1.

Results:

A total of 32 patients were studied. Initially, six patients were treated at each of the irinotecan dose levels (200, 250 and 300 mg/m2) combined with UFT 250 mg/m2/day and LV 90 mg/day. DLTs consisting of grade 3 or 4 diarrhoea and febrile neutropenia were observed in one of 20 patients at 250 mg/m2 and three of six patients at the 300 mg/m2 irinotecan dose level. Having defined the MTD, the 250 mg/m2 dose level was established as the recommended dose (RD) and expanded to 20 patients in whom treatment was generally well tolerated. The overall response rate was 19%, with five patients having a partial response (PR) and 18 stable disease (SD) out of 32 response-evaluable patients.

Conclusion:

UFT and LV can be safely combined with irinotecan. The RDs for future studies are UFT 250 mg/m2/day and LV 90 mg/day given on days 1–14, with irinotecan 250 mg/m2 administered on day 1, every 3 weeks. This combination is well tolerated and active. Further investigation of UFT and LV in combination with irinotecan is warranted in patients with colorectal cancer.

Key words: chemotherapy, colorectal cancer, irinotecan, leucovorin, tegafur/uracil


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Jpn J Clin OncolHome page
H. Ishida, Y. Miyake, M. Fukunaga, Y. Watanabe, T. Kato, H. Takemoto, and H. Furukawa
A Feasibility Study of UFT/LV and Irinotecan (TEGAFIRI) in Advanced or Metastatic Colorectal Cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) PROG 0304
Jpn. J. Clin. Oncol., September 1, 2009; 39(9): 601 - 605.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
A. Goto, Y. Yamada, H. Yasui, K. Kato, T. Hamaguchi, K. Muro, Y. Shimada, and K. Shirao
Phase II study of combination therapy with S-1 and irinotecan in patients with advanced colorectal cancer
Ann. Onc., June 1, 2006; 17(6): 968 - 973.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.