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Dose escalation study of tezacitabine in combination with cisplatin in patients with advanced cancer
Author(s) -
Flaherty Keith T.,
Stevenson James P.,
Gallagher Maryann,
Giantonio Bruce,
Algazy Kenneth M.,
Sun Weijing,
Haller Daniel G.,
O'Dwyer Peter J.
Publication year - 2003
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.11273
Subject(s) - medicine , neutropenia , cisplatin , toxicity , leukopenia , cancer , chemotherapy , gastroenterology
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