A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
OBJECTIVES:
- Determine the maximum tolerated dose of Huang Lian (Chinese herb) in patients with
advanced solid tumors.
- Determine the optimal pharmacologic, molecular, and biologic parameters of this
treatment regimen in these patients.
- Assess the preliminary therapeutic activity of this treatment regimen in this patient
population.
OUTLINE: This is a dose-escalation study.
Patients receive oral Huang Lian (Chinese herb) 4 times daily. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of Huang Lian until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-liming toxicity.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Gary K. Schwartz, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000068538
NCT00014378
October 2000
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |