Herbal Therapy in Treating Women With Metastatic Breast Cancer

September 13, 2012 updated by: University of California, San Francisco

A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Francisco, California, United States, 94115
    - UCSF Comprehensive Cancer Center
- Florida
  - Plantation, Florida, United States, 33324
    - Cancer Research Network, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Hope S. Rugo, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000069155
UCSF-CRO-00758
UCSF-IND-59521
NCI-G01-2043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.