NCT00049608终止1 期
A Phase I Study Of The Effect Of Mistletoe Extract, A Complementary Medicine Botanical, On Pharmacokinetics, Pharmacodynamics And Safety Of Gemcitabine In Patients With Advanced Solid Tumors
National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2002年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Mistletoe may slow the growth of tumor cells and may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine with mistletoe in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in these patients.
- Determine tumor response in patients treated with this regimen.
- Determine the time to neutrophil count recovery in patients treated with this regimen.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of gemcitabine and mistletoe in 2 stages.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following:
- •Breast or colorectal cancer that has failed first-line chemotherapy
- •Non-small cell lung cancer
- •Pancreatic Cancer
- •No CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Male or female
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •No clinically significant hepatic dysfunction
- •Creatinine no greater than 2.5 mg/dL
- •No clinically significant renal dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •HIV negative
- •No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior mistletoe
- •Chemotherapy
- •See Disease Characteristics
- •No prior gemcitabine
- •More than 30 days since prior chemotherapy and recovered
- •Endocrine therapy
- •More than 30 days since prior glucocorticosteroid therapy
- •Radiotherapy
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •At least 30 days since prior investigational agents
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (2)
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