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Dose escalation study of tezacitabine in combination with cisplatin in patients with advanced cancer
Article first published online: 1 APR 2003
Copyright © 2003 American Cancer Society
Volume 97, Issue 8, pages 1985–1990, 15 April 2003
How to Cite
Flaherty, K. T., Stevenson, J. P., Gallagher, M., Giantonio, B., Algazy, K. M., Sun, W., Haller, D. G. and O'Dwyer, P. J. (2003), Dose escalation study of tezacitabine in combination with cisplatin in patients with advanced cancer. Cancer, 97: 1985–1990. doi: 10.1002/cncr.11273
- Issue published online: 1 APR 2003
- Article first published online: 1 APR 2003
- Manuscript Accepted: 20 DEC 2002
- Manuscript Received: 13 DEC 2002
- Manuscript Revised: 13 DEC 2002
- Matrix Pharmaceuticals
- Phase I trial;
- deoxycitidine analog;
- combination chemotherapy
The authors performed a dose escalation study of cisplatin and the novel deoxycytidine analog, tezacitabine, to determine the maximum tolerated dose of the combination.
Twenty-three patients with advanced cancer and good performance status were accrued to 3 dose levels of tezacitabine (150–270 mg/m2) and cisplatin (50 mg/m2). Using a 28-day treatment cycle, both drugs were administered on Days 1 and 15.
Hematologic toxicity was the most frequently observed side effect and was dose limiting. Grade 3 or 4 neutropenia and thrombocytopenia complicated 75% and 31% of all cycles, respectively. Nonhematologic toxicities were mild. Among 18 evaluable patients, 2 with upper gastrointestinal tract tumors achieved partial responses and 4 had stable disease.
Based on dose-limiting neutropenia and thrombocytopenia at the highest dose level, the recommended Phase II doses are 200 mg/m2 of tezacitabine and 50 mg/m2 of cisplatin. Cancer 2003;97:1985–90. © 2003 American Cancer Society.