A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Hope S. Rugo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000069155
NCT ID:
NCT00028977
Start Date:
August 2001
Completion Date:
April 2006
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Cancer Research Network, Incorporated | Plantation, Florida 33324 |
