Abstract |
Paclitaxel ( Taxol) is formulated in 50% Cremophor EL (CrEL)/absolute ethanol for clinical use. In order to reduce vehicle-related side effects, Genetaxyl was developed to have paclitaxel formulated in a solution containing lesser amounts of CrEL and ethanol plus 2 other solvents. The purpose of the study was to evaluate the efficacy and safety of Genetaxyl as first-line therapy to treat breast cancer patients. Patients with newly diagnosed stage III (N = 8) or IV (N = 10), or recurrent (N = 11) breast cancer received single-agent Genetaxyl at 175 mg/m(2) administered in a 3-h infusion every 3 weeks for 3-6 cycles. A total of 148 cycles were delivered to 29 patients. The overall response rate was 41.4% (95% confidence interval, 23.4 to 59.2%), and that of patients with metastatic disease (N = 20) was 30%. Median survival for all patients was 32.4 months and 24.3 months for patients having metastatic disease. The toxicity profile seems favorable, especially regarding myelosuppression and myalgia/ arthralgia. No severe hypersensitivity reaction occurred. These phase II trial results demonstrate that a 60% reduction of CrEL by Genetaxyl's formulation does not affect the activity of paclitaxel and could allow for better control of several CrEL-related toxicities.
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Authors | Ta-Chung Chao, Zyting Chu, Ling-Ming Tseng, Tzeon-Jye Chiou, Ruey-Kuen Hsieh, Wei-Shu Wang, Chueh-Chuan Yen, Muh-Hwa Yang, Liang-Tsai Hsiao, Jin-Hwang Liu, Po-Min Chen |
Journal | Investigational new drugs
(Invest New Drugs)
Vol. 23
Issue 2
Pg. 171-7
(Mar 2005)
ISSN: 0167-6997 [Print] United States |
PMID | 15744594
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Paclitaxel
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Topics |
- Adult
- Aged
- Antineoplastic Agents, Phytogenic
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, mortality, pathology)
- Chemistry, Pharmaceutical
- Humans
- Infusions, Intravenous
- Middle Aged
- Paclitaxel
(adverse effects, therapeutic use)
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