Dose escalation study of tezacitabine in combination with cisplatin in patients with advanced cancer

✍ Scribed by Keith T. Flaherty; James P. Stevenson; Maryann Gallagher; Bruce Giantonio; Kenneth M. Algazy; Weijing Sun; Daniel G. Haller; Peter J. O'Dwyer

• Publisher: John Wiley and Sons
• Year: 2003
• Tongue: English
• Weight: 76 KB
• Volume: 97
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.11273

✦ Synopsis

Abstract

BACKGROUND

The authors performed a dose escalation study of cisplatin and the novel deoxycytidine analog, tezacitabine, to determine the maximum tolerated dose of the combination.

METHODS

Twenty‐three patients with advanced cancer and good performance status were accrued to 3 dose levels of tezacitabine (150–270 mg/m^2^) and cisplatin (50 mg/m^2^). Using a 28‐day treatment cycle, both drugs were administered on Days 1 and 15.

RESULTS

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.

CONCLUSIONS

Based on dose‐limiting neutropenia and thrombocytopenia at the highest dose level, the recommended Phase II doses are 200 mg/m^2^ of tezacitabine and 50 mg/m^2^ of cisplatin. Cancer 2003;97:1985–90. © 2003 American Cancer Society.

DOI 10.1002/cncr.11273