Evaluation of Tomudex in patients with recurrent or metastatic squamous cell carcinoma of the head and neck : a Southwest Oncology Group study

A phase II trial of Tomudex (raltitrexed, ZD 1694), a new thymidylate synthase inhibitor, was performed in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. This trial demonstrated that Tomudex was well tolerated in this patient population. Nausea and vomiting were...

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Bibliographic Details
Published in:Investigational new drugs 1998-01, Vol.16 (3), p.271-274
Main Authors: SAMLOWSKI, W. E, LEW, D, KUEBLER, P. J, KOLODZIEJ, M. A, MEDINA, J. E, MANGAN, K. F, MOORE, D. F, SCHULLER, D. E, ENSLEY, J. F
Format: Article
Language:English
Subjects:
Aged
Antimetabolites, Antineoplastic - therapeutic use
Antineoplastic agents
Biological and medical sciences
Cancer therapies
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - secondary
Carotid arteries
Chemotherapy
Creatinine
Diarrhea
Enzymes
Female
Head and Neck Neoplasms - drug therapy
Head and Neck Neoplasms - pathology
Humans
Male
Medical sciences
Metastasis
Middle Aged
Nausea
Neoplasm Recurrence, Local - drug therapy
Neutropenia
Oncology
Patients
Pharmacology. Drug treatments
Quinazolines - therapeutic use
Radiation therapy
Registration
Response rates
Squamous cell carcinoma
Survival Analysis
Thiophenes - therapeutic use
Toxicity
Vomiting
Womens health
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Summary:A phase II trial of Tomudex (raltitrexed, ZD 1694), a new thymidylate synthase inhibitor, was performed in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. This trial demonstrated that Tomudex was well tolerated in this patient population. Nausea and vomiting were minimal, and hematologic toxicities were relatively infrequent. Only one patient was withdrawn from the study due to toxicity (grade 4 diarrhea). One patient exsanguinated from a rent in the carotid artery in an area of tumor involvement, and was categorized as a grade 5 toxicity. Thus 25/27 patients were able to complete at least 2 cycles of treatment. Tomudex demonstrated a 3.7% response rate (95% CI 0.1-19%), with a median survival of 6 months in this highly resistant disease population. Tomudex is not considered active enough as monotherapy for further evaluation in this disease population.
ISSN:0167-6997
1573-0646
DOI:10.1023/A:1006178808095