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Herbal Therapy in Treating Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: UCSF Helen Diller Family Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028977
  Purpose

RATIONALE: The Chinese herb Scutellaria barbata contains ingredients that may slow the growth of cancer cells and may be an effective treatment for metastatic breast cancer.

PURPOSE: Phase I/II trial to study the effectiveness of Scutellaria barbata in treating women who have metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: herba scutellaria barbata
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of Scutellaria barbata (Chinese herbal extract) in terms of tumor response in women with metastatic breast cancer.
  • Determine the safety and toxicity of this therapy in these patients.
  • Determine the feasibility of this therapy in these patients.
  • Determine the time to progression, overall survival, and resource utilization of patients treated with this therapy.
  • Determine the quality of life of patients treated with this therapy.
  • Determine the bioavailability and pharmacokinetics of this therapy in these patients.

OUTLINE: Patients receive oral Scutellaria barbata (Chinese herbal extract) twice daily for 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer (may include original primary cancer diagnosis)
  • Measurable disease
  • Metastatic involvement with minimal or no symptoms

    • Solitary metastases require histological confirmation
  • No extensive liver involvement (more than 50% of liver parenchyma)
  • No lymphangitic pulmonary involvement
  • CNS involvement or spinal cord compression allowed if stabilized by therapy for more than 3 months
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 6 months

Hematopoietic:

  • WBC at least 2,500/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • See Disease Characteristics
  • Bilirubin no greater than 1.7 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of multiple or severe food or medicine allergies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 week since prior biologic therapy
  • No concurrent anticancer biologic therapy

Chemotherapy:

  • At least 1 week since prior chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy:

  • At least 1 week since prior hormonal therapy
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Recovered from prior anticancer therapy
  • At least 1 week since prior investigational agents
  • At least 1 week since prior herbal medications
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • Concurrent pamidronate allowed
  • Concurrent acupuncture or other nonherbal therapy allowed
  • Concurrent nutritional vitamin supplementation (up to 5 times recommended daily allowance) allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028977

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Florida
Cancer Research Network, Incorporated
Plantation, Florida, United States, 33324
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Study Chair: Hope S. Rugo, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069155, UCSF-CRO-00758, UCSF-IND-59521, NCI-G01-2043
Study First Received: January 4, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00028977     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009