Phase I and II Trial of Huanglian, a Novel Botanical Against Breast Cancer That Enhances Taxol Activity

摘要

Huanglian is a botanical agent prepared as a tea form the roots of Coptis chinensis. We reported that huanglian potently inhibits the growth of a number cancer cells in vitro in a dose-dependent manner, with maximal inhibition at low micromolar concentrations (Li x. et al. Molecular Pharmacology, 58:1287- 1293,2000). MCF-7 and MDA-468 breast cancer lines were particularly sensitive to huanglian. In addition, huanglian was also shown to enhance the effect of palitaxel, supporting the future development of huanglian in combination with paclitaxel for the treatment of patients with metastatic breast cancer. The overall goal for this grant is to develop new therapeutic approaches in the treatment of patients with metastatic breast cancer based utilizing the Chinese botanical huanglian. The specific aims are to (1) conduct a phase I clinical trial of huanglian with both toxicity and efficacy endpoints, and (2) following the single agent trial, conduct a phase I/Il clinical trial of huanglian in combination with paclitaxel in the treatment of patient with metastatic breast cancer. To date, we have entered 22 patients to the single agent trial of huanglian. We are currently evaluating a dose of 8.25 gm/day. We encouraged by preliminary evidence of clinical and biological activity.