Journal article
A phase II study of milataxel : a novel taxane analogue in previously treated patients with advanced colorectal cancer
Cancer chemotherapy and pharmacology, Vol.61(3), pp.453-458
2008
DOI: 10.1007/s00280-007-0489-5
PMID: 17516069
Abstract
Background
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.
Patients and results
Forty-four eligible patients were entered. Milataxel was administered intravenously every 3 weeks at the dose of 35 mg/m2. 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.
Conclusions
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/m2 every 3 weeks. Clinical activity was not demonstrated in patients with advanced previously treated CRC.
Details
- Title: Subtitle
- A phase II study of milataxel : a novel taxane analogue in previously treated patients with advanced colorectal cancer
- Creators
- Ramesh K RAMANATHAN - Division of Hematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United StatesDaniel BERG - Department of Internal Medicine, Division of Hematology/Oncology, University of Iowa, Iowa City, IA 52242, United StatesJoel PICUS - Washington School of Medicine, Saint Louis, MO 63110, United StatesHoward HOCHSTER - New York University School of Medicine, New York, NY 10016, United StatesAlien COHN - Rocky Mountain Cancer Center, Denver, CO 80218, United StatesHaralambos RAFTOPOULOS - Columbia University Medical Center, New York, NY 10032, United StatesStephen BERNARD - University of North Carolina, Chapel Hill, Chapel Hill, NC 27599, United StatesA. Craig LOCKHART - Vanderbilt University Medical Center, Nashville, TN 37232, United StatesGary FRENETTE - Carolinas Hematology-Oncology Associates, Charlotte, NC 28203, United StatesJohn MACDONALD - Saint Vincent's Comprehensive Cancer Center, New York, NY 10011, United StatesSusan MELIN - Wake Forest University, Winston-Salem, NC 27157, United StatesFrank BRESCIA - Medical University of South Carolina, Charleston, SC 29425, United States
- Resource Type
- Journal article
- Publication Details
- Cancer chemotherapy and pharmacology, Vol.61(3), pp.453-458
- Publisher
- Springer
- DOI
- 10.1007/s00280-007-0489-5
- PMID
- 17516069
- ISSN
- 0344-5704
- eISSN
- 1432-0843
- Language
- English
- Date published
- 2008
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094392902771
Metrics
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