A phase II study of milataxel: a novel taxane analogue in previously treated patients with advanced colorectal cancer

Autor: Allen Lee Cohn, Howard S. Hochster, Haralambos Raftopoulos, John S. Macdonald, Susan A. Melin, Ramesh K. Ramanathan, A. Craig Lockhart, Joel Picus, Daniel J. Berg, Frank J. Brescia, Gary Frenette, Stephen A. Bernard
Rok vydání: 2007
Předmět:
Zdroj: Cancer Chemotherapy and Pharmacology. 61:453-458
ISSN: 1432-0843
0344-5704
DOI: 10.1007/s00280-007-0489-5
Popis: Milataxel is a novel taxane analog, with evidence of enhanced preclinical activity compared to paclitaxel and docetaxel, especially in cell lines that over express P-glycoprotein. Based on preclinical data that milataxel may be active in colorectal cancer (CRC), a phase II study was performed in patients with advanced previously treated CRC.Forty-four eligible patients were entered. Milataxel was administered intravenously every 3 weeks at the dose of 35 mg/m(2). No objective responses were noted, stable disease was seen in three patients. The median time to progression was 1.4 months (95% CI of 1.2-2.4 months). Three subjects developed neutropenic sepsis and two died. The most frequent grade 3/4 adverse events were neutropenia (57%), leukopenia (27%), dehydration (14%), neuropathy (16%), diarrhea (14%) and thrombocytopenia (14%). The pharmacokinetics of milataxel was assessed in five subjects. The mean milataxel elimination half-life was 64 h and the mean area under the plasma concentration-time curve was 1,708 ng h/ml.A syndrome of neutropenic sepsis and diarrhea can be life threatening and close surveillance is needed in patients treated with milataxel at the dose of 35 mg/m(2) every 3 weeks. Clinical activity was not demonstrated in patients with advanced previously treated CRC.
Databáze: OpenAIRE
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