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 (23)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Seitz, J.-F.
Right arrow Articles by Douillard, J.-Y.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Seitz, J.-F.
Right arrow Articles by Douillard, J.-Y.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Annals of Oncology 13:1072-1079, 2002
© 2002 European Society for Medical Oncology

Original Paper

Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients

J.-F. Seitz1,+, J. Bennouna2, B. Paillot3, E. Gamelin4, E. François5, T. Conroy6, J.-L. Raoul7, Y. Becouarn8, F. Bertheault-Cvitkovic9, M. Ychou10, S. Nasca11, A. Fandi12, P. Barthelemy13 and J.-Y. Douillard2

1 Institut Paoli-Calmettes, University of the Mediterranean, Marseille; 2 Centre René Gauducheau, St Herblain; 3 CHU de Rouen, Rouen; 4 Centre Paul Papin, Angers; 5 Centre Antoine Lacassagne, Nice; 6 Center Alexis Vautrin, Vandoeuvre Les Nancy; 7 Centre Eugène Marquis, Rennes; 8 Institut Bergonié, Bordeaux; 9 Center René Huguenin, Saint Cloud; 10 Centre Val D’Aurelle Paul Lamarque, Montpellier; 11 Institut Jean Godinot, Reims, France; 12 AstraZeneca, Macclesfield, UK; 13 AstraZeneca, Rueil-Malmaison, France

Received 24 January 2002; accepted 18 February 2002

Background:

This multicenter, phase II, open-label study evaluated the antitumor efficacy and safety of oxaliplatin and raltitrexed (Tomudex) in non-pretreated advanced colorectal cancer patients.

Patients and methods:

Seventy-one patients received oxaliplatin 130 mg/m2 and raltitrexed 3 mg/m2 intravenously on an outpatient basis every 3 weeks. All patients had histologically proven metastatic colorectal adenocarcinoma, performance status <=2 and good baseline organ function. Most (56%) had only one disease site. All patients were assessed for safety, and 66 of 69 eligible patients were assessed for response.

Results:

A total of 404 cycles were administered, with a median of six cycles per patient (range 1–12 cycles). Relative dose intensities were 0.98 and 0.98 for oxaliplatin and raltitrexed, respectively. The most common grade 3–4 toxicities (National Cancer Institute Common Toxicity Criteria) among treated patients were as follows: neutropenia (21 patients, 30%), asthenia (eight, 11%), diarrhea (12, 17%), liver function test abnormalities (24, 34%), nausea (nine, 13%) and vomiting (nine, 13%). Two treatment-related deaths occurred (hematotoxicity in one patient and gastrointestinal toxicity in the other) and two further deaths were possibly related to treatment (hepatic dysfunction in one patient and neuropathy in the other). Thirty-seven objective responses (one complete) were obtained [objective response rate 54%; 95% confidence interval (CI) 42% to 65%] in eligible patients. The median response duration was 8.5 months (95% CI 6.7–12.2 months), while median progression-free and overall survival among eligible patients were 6.2 (95% CI 5.1–6.9 months) and 14.6 months (95% CI 11.0–18.9 months), respectively.

Conclusions:

The present study confirms the feasibility of the raltitrexed plus oxaliplatin combination and its activity in non-pretreated advanced colorectal cancer patients.

Key words: colorectal cancer, first-line chemotherapy, metastatic disease, oxaliplatin, raltitrexed


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
 JCOHome page
G. Tisman, D. MacDonald, N. Shindell, E. Reece, P. Patel, N. Honda, E. K. Nishimora, J. Garris, W. Shannahan, N. Chisti, et al.
Oxaliplatin Toxicity Masquerading As Recurrent Colon Cancer
J. Clin. Oncol., August 1, 2004; 22(15): 3202 - 3204.
[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.