NCT00114205已完成1 期
Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose by adverse event evaluation 1 month after treatment
研究概览
简要总结
RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients.
- Determine the response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 or cytologically confirmed malignant pleural effusion (MPE)
- •Symptomatic disease
- •Candidate for thoracoscopic surgery for treatment of MPE
- •No known or suspected ipsilateral pleurodesis that would preclude surgery
- •No bilateral MPEs
- •No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR
- •Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)
- •Bilirubin normal
- •INR ≤ 1.5
- •Creatinine ≤ 1.8 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No peripheral neuropathy > grade 1
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No concurrent systemic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose by adverse event evaluation 1 month after treatment
次要结局
- Pharmacokinetics by serum and pleural fluid analyses through 1 month
- Clinical response by chest x-ray response and survival
研究者
研究点 (1)
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