A Phase II Trial of Raltitrexed (Tomudex<sup>®</sup>) in Advanced Pancreatic and Biliary Carcinoma

Vol. 68, No. 4-6, 2005

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Clinical Study

A Phase II Trial of Raltitrexed (Tomudex^®) in Advanced Pancreatic and Biliary Carcinoma
Eric François^a, M. Hebbar^b, J. Bennouna^c, D. Mayeur^d, H. Perrier^e, E. Dorval^f, C. Martin^g, H. Bourgeois^h, P. Barthélemyⁱ, J.Y. Douillard^c

^aCentre Antoine-Lacassagne, Nice;
^bCentre Hospitalo-Universitaire Huriez, Lille;
^cCentre René-Gauducheau, Nantes;
^dHôpital de Versailles, Le Chesnay;
^eHôpital St Joseph, Marseille;
^fCentre Hospitalo-Universitaire Régional Trousseau, Tours;
^gCentre Hospitalier, Annecy;
^hCentre Hospitalo-Universitaire Régional La Miletrie, Poitiers, and
ⁱAstraZeneca, Rueil-Malmaison, France

Address of Corresponding Author

Oncology 2005;68:299-305 (DOI: 10.1159/000086968)

Key Words

Biliary carcinoma
Clinical benefit
Pancreatic cancer
Quality of life
Raltitrexed

Abstract

Purpose: To evaluate the impact of raltitrexed (Tomudex^®) on the quality of life in a multicenter, phase II study in advanced pancreatic and biliary carcinomas. Patients and Methods: Forty-six patients with advanced, histologically proven pancreatic (n = 37, 80.4%) or biliary (n = 9, 19.6%) carcinoma received 3 mg/m² raltitrexed intravenously once every 3 weeks. For the quality of life assessments, EORTC QLQ-C30 was used, and the evaluation of the clinical benefit was performed according to the 4 criteria of the clinical benefit response. All patients were assessed for safety, and 41 patients were evaluable for objective response. Results: Patients (63% male/37% female) had a mean age of 61.2 years, 71.7% had a PS of 0-1, 78.3% had metastatic disease, and 63% had at least 2 tumoral sites. A total of 176 cycles were administered with a mean of 4 cycles per patient (range 1-12). Three out of 43 patients evaluable for EORTC QLQ-C30 (7.0%; CI_95% 1.4-19.0%) had a quality of life improvement. Thirty-two patients fulfilled the 4 criteria required to evaluate the clinical benefit response; 5 were responders (15.6%; CI_95% 5.3-32.8%); 1 patient was a good responder based on both the EORTC questionnaire and the clinical benefit response. Forty-one patients were assessable for response, 3 responded to treatment (response rate: 6.5 %; CI_95% 1.3-17.9%). Median survival was 4.6 months (CI_95% 2.9-8.2 months), the 1-year survival rate was 21.8%. The most common grade 3-4 toxicities were neutropenia (8%), leukopenia (8%), thrombopenia (6%), anemia (6%), liver enzyme elevations (11%), asthenia (9%), vomiting (9%), abdominal pain (7%), and phlebitis (6%). One treatment-related death occurred (neutropenic sepsis). Conclusion: Raltitrexed appeared to be generally well tolerated and showed a clinical benefit response and/or quality of life improvement in a limited number of patients.

Author Contacts

Eric François, MD
Centre Antoine Lacassagne
33 Avenue de Valombrose
FR-06189 Nice Cedex 2 (France)
Tel. +33 4 92 03 11 14, Fax +33 4 92 03 10 46, E-Mail eric.francois@cal.nice.fnclcc.fr

Article Information

Received: April 21, 2004
Accepted after revision: October 3, 2004
Published online: July 12, 2005
Number of Print Pages : 7
Number of Figures : 0, Number of Tables : 3, Number of References : 32

Medline Abstract (ID 16020956)

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