Phase IIstudy of ZD1694 in patients with advanced gastric cancer

Neal J. Meropol, Richard Pazdur, Mark Vincent, James K V Willson, David P. Kelsen, Harold O. Douglass

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

ZD1694 (Tomudex(TM)), a quinazoline folate analogue, is a potent and selective thymidylate synthase inhibitor. A phase II trial was undertaken to determine the efficacy and toxicity of ZD1694 in patients with advanced, measurable gastric adenocarcinoma, ZD1694, 3.0 mg/m2, was administered as a 15 min intravenous infusion every three weeks. Tumor measurements were obtained for response assessment every six weeks. Clinical examinations, adverse event assessments, and clinical laboratory tests were performed every three weeks. Thirty-three patients were enrolled. There were no objective responses to ZD1694. In general, treatment was well-tolerated. Grade 3 and 4 toxicities were infrequent, and included mucositis, nausea and vomiting, leukopenia, thrombocytopenia, and elevations of liver enzymes. Mild to moderate asthenia was common. Toxicities with ZD1694 were reversible and manageable. In conclusion, ZD 1694 has an acceptable toxicity profile but shows no antitumor activity in patients with advanced gastric cancer.

Original languageEnglish (US)
Pages (from-to)628-630
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume19
Issue number6
DOIs
StatePublished - Nov 26 1996

Keywords

  • Chemotherapy
  • Gastric cancer
  • Thymidylate synthase
  • Tomudex
  • ZD1694

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Meropol, N. J., Pazdur, R., Vincent, M., Willson, J. K. V., Kelsen, D. P., & Douglass, H. O. (1996). Phase IIstudy of ZD1694 in patients with advanced gastric cancer. American Journal of Clinical Oncology: Cancer Clinical Trials, 19(6), 628-630. https://doi.org/10.1097/00000421-199612000-00020