NCT00028977已完成1 期
A Pilot Safety, Feasibility, Efficacy And Correlative (Phase I/II) Study Assessing Herba Scutellaria Barbatae (HSB) For Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •WBC at least 2,500/mm^3
- •Platelet count at least 75,000/mm^3
- •See Disease Characteristics
- •Bilirubin no greater than 1.7 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •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
- •Not specified
- •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
排除标准
- 未提供
研究者
研究点 (2)
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