A phase I trial of a new antiemetic drug--clebopride malate--in cisplatin-treated patients.
Ann Oncol
; 3(2): 141-3, 1992 Feb.
Article
em En
| MEDLINE
| ID: mdl-1606084
ABSTRACT
Clebopride, a new benzamide derivative, has, in common with the other members of this group, antidopaminergic activity. In animals, its therapeutic ratio is superior to that of metoclopramide at doses free of side effects associated with hyperprolactinemia and extrapyramidal symptoms. The present study was designed to define the maximum tolerated dose (MTD) in patients with advanced histologically-proven cancer, treated with cisplatin at a dose of greater than 50 mg/m2. Most of them were pretreated and refractory to standard antiemetics. Clebopride was started at a dosage of 0.10 mg/kg in a group of 6 patients and escalated by 0.2 mg at each dose level. A total of 30 patients were included. Side effects include somnolence, diarrhea and extrapyramidal-like symptoms. The latter occurred at almost all dose levels in 14% of the cycles and limited continuation of the study. Activity in this group of patients was encouraging but, considering the rate of extrapyramidal symptoms, further dose escalation is not indicated and activity at lower, nontoxic levels should be investigated.
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Coleções:
01-internacional
Contexto em Saúde:
3_ND
Base de dados:
MEDLINE
Assunto principal:
Vômito
/
Benzamidas
/
Cisplatino
/
Antieméticos
/
Náusea
/
Neoplasias
Limite:
Adolescent
/
Adult
/
Aged
/
Humans
/
Middle aged
Idioma:
En
Revista:
Ann Oncol
Ano de publicação:
1992
Tipo de documento:
Article