Dasatinib in previously treated metastatic colorectal cancer: a phase II trial of the University of Chicago Phase II Consortium.
Invest New Drugs
; 30(3): 1211-5, 2012 Jun.
Article
em En
| MEDLINE
| ID: mdl-21552992
ABSTRACT
BACKGROUND:
Treatment options for metastatic colorectal cancer (CRC) are limited after a fluoropyrimidine, oxaliplatin and irinotecan; novel agents need to be explored in this setting. Dasatinib, an oral inhibitor of Src family kinases, inhibits proliferation in CRC cell lines and has antitumor activity in CRC xenograft models. PATIENTS ANDMETHODS:
We conducted a multi-center phase II trial of dasatinib in unresectable, previously-treated metastatic CRC patients. No more than 2 prior chemotherapy regimens were permitted, which must have contained a fluoropyrimidine, oxaliplatin and irinotecan. The primary endpoint was progression-free survival (PFS) at 4 months. The Simon two-stage design required that at least 5 of the first 19 patients be progression-free at 4 months to expand to a second stage.RESULTS:
Nineteen patients enrolled at 9 centers. The study was terminated after the first stage due to lack of efficacy. There were no objective responses; 1 patient (5%) had stable disease for 7.3 months. The PFS rate at 4 months was 5.3% (90% CI 0.3, 22.6). Median PFS was 1.6 months (90% CI 1.4, 1.8). Median overall survival was 5.1 months (90% CI 2.4, 6.3). Grade 3/4 toxicities included fatigue in 16% of patients, and anemia, anorexia, nausea/vomiting and dyspnea in 11%.CONCLUSION:
Dasatinib is inactive as a single agent in previously treated metastatic CRC patients.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Pirimidinas
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Tiazóis
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Neoplasias Colorretais
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Inibidores de Proteínas Quinases
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Invest New Drugs
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Estados Unidos