Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014378
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: The Chinese herb Huang Lian contains ingredients that may slow the growth of cancer cells and may be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of Huang Lian in treating patients who have advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: Chinese Herb Huanglian (Coptis chinesis) Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of The Chinese Herb Huanglian (Coptis Chinesis) In Patients With Advanced Solid Tumors
Study Start Date : October 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Experimental: Chinese Herb Huanglian (Coptis chinesis) Drug: Chinese Herb Huanglian (Coptis chinesis)
Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists
  • Measurable or evaluable disease
  • No CNS primary tumor or metastasis



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • WBC greater than 3,500/mm^3
  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No history of cardiac arrhythmias (including atrial fibrillation)
  • No congestive heart failure
  • No angina or myocardial infarction within the past 6 months
  • QTc interval no greater than 0.48 sec


  • Potassium at least 3.5 mEq/L
  • Magnesium at least 1.4 mEq/L
  • No mental incapacity that would preclude informed consent
  • No serious or uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified


  • At least 2 weeks since prior herbal therapy for cancer and recovered
  • No concurrent class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide, sotalol, amiodarone, ibutilide, almokalant, or dofetilide)
  • No concurrent tricyclic antidepressants (e.g., amitriptyline, doxepin, desipramine, imipramine, or clomipramine)
  • No concurrent antiseizure medication (including dilantin and phenobarbital) for any underlying seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014378

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary K. Schwartz, MD Memorial Sloan Kettering Cancer Center

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00014378     History of Changes
Other Study ID Numbers: 00-061
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific