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 synth ase inhibitor, was performed in patients with recurrent or metastatic squam ous cell carcinoma of the head and neck. This trial demonstrated that Tomud ex was well tolerated in this patient population. Nausea and vomiting were minimal, and hematologic toxicities were relatively infrequent. Only one pa tient was withdrawn from the study due to toxicity (grade 4 diarrhea).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 patient s were able to complete at least 2 cycles of treatment. Tomudex demonstrate d 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 act ive enough as monotherapy for further evaluation in this disease population .