Trial of Huanglian, a Novel Botanical against Breast Cancer that Enhances Taxol Activity. Phase 1 and 2
Abstract
Huanglian is a botanical prepared from the root of Coptis chinensis and deltoidea. We reported that huanglian inhibits growth of breast cancer cells in vitro in a dose-dependent manner (Li X. et al. Molecular Pharmacology 58: 1287-1293 2000). Based on these results we developed huanglian as an herbal extract packaged in 250 mg capsules suitable for human clinical trials. We have treated 26 patients on the phase I trial of huanglian. We observed grade 3 diarrhea in one of six patients at cohorts 6 (5.25 gm/day) and 8 (8.25 gm/day) respectively. However because of capsule number at this highest dose (33 capsules/day in 4 divided doses) further dose escalation did not appear feasible. We therefore elected to increase the amount of huanglian in the capsules from 250 to 500 mg. It took over a year to identify a new source of root from China that would meet our strict biochemical" profile for Huanglian. With 500 mg capsules we have now been able to escalate to a dose of 10 gm/day. We have had one patient with dose-limiting nausea and vomiting and the cohort is expanded to 6 patients. We anticipate recommending a dose of 8 gm/day for phase II trials.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2005
- Accession Number
- ADA484108
Entities
People
- Gary K. Schwartz
Organizations
- Memorial Sloan Kettering Cancer Center