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- Title
A phase I and pharmacokinetic study of silybin-phytosome in prostate cancer patients.
- Authors
Thomas Flaig; Daniel Gustafson; Lih-Jen Su; Joseph Zirrolli; Frances Crighton; Gail Harrison; A. Pierson; Rajesh Agarwal; L. Glodé
- Abstract
<div class="abstract"><a name="abs1"/><span class="abstractheading">Summary??</span>Silibinin is a polyphenolic flavonoid isolated from milk thistle with anti-neoplastic activity in severalin vitroandin vivomodels of cancer, including prostate cancer. Silybin-phytosome is a commercially available formulation containing silibinin. This trial was designed to assess the toxicity of high-dose silybin-phytosome and recommend a phase II dose. Silybin-phytosome was administered orally to prostate cancer patients, giving 2.5?20?g daily, in three divided doses. Each course was 4 weeks in duration. Thirteen patients received a total of 91 courses of silybin-phytosome. Baseline patient characteristics included: median age of 70 years, median baseline prostate specific antigen (PSA) of 4.3?ng/ml, and a median ECOG performance status of 0. The most prominent adverse event was hyperbilirubinemia, with grade 1?2 bilirubin elevations in 9 of the 13 patients. The only grade 3 toxicity observed was elevation of alanine aminotransferase (ALT) in one patient; no grade 4 toxicity was noted. No objective PSA responses were observed. We conclude that 13 g of oral silybin-phytosome daily, in 3 divided doses, appears to be well tolerated in patients with advanced prostate cancer and is the recommended phase II dose. Asymptomatic liver toxicity is the most commonly seen adverse event.</div>
- Subjects
CANCER patients; PROSTATE cancer; PHARMACOKINETICS; ANTIGENS
- Publication
Investigational New Drugs, 2007, Vol 25, Issue 2, p139
- ISSN
0167-6997
- Publication type
Article
- DOI
10.1007/s10637-006-9019-2