NCT00020007已完成1 期
A Phase I Study of Isolated Lung Perfusion With Paclitaxel and Moderate Hyperthermia in Patients With Unresectable Pulmonary Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating paclitaxel to several degrees above body temperature and infusing it to the affected area around the tumor may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel given by hyperthermic perfusion in treating patients with lung cancer or lung metastases that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of paclitaxel administered via hyperthermic retrograde isolated lung perfusion in patients with unresectable pulmonary malignancies.
- Determine the nature of the toxic effects of this regimen in this patient population.
- Evaluate the pharmacokinetic profile of this regimen in these patients.
- Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study of paclitaxel.
Patients undergo posterolateral thoracotomy or median sternotomy. Patients receive paclitaxel over 90 minutes administered via hyperthermic retrograde isolated lung perfusion. The entire surgery lasts approximately 4 hours.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
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 unresectable primary lung cancer or pulmonary metastases that are unresectable on the basis of technical considerations or are sufficiently numerous that recurrent, potentially inoperable disease is highly probable
- •Bilateral metastases allowed
- •Unresectable bronchoalveolar carcinomas allowed
- •Previously treated primary lung cancer allowed
- •Disease outside confines of thorax allowed, provided bulk of disease in the chest is clearly the greatest threat to survival and/or extrathoracic disease is controlled
- •No potentially treatable pulmonary metastases from lymphomas or germ cell tumors
- •No biopsy proven interstitial fibrosis, radiation induced pneumonitis, or evidence of significant pulmonary hypertension by history, radiologic, echocardiographic, or catheterization studies
- •No active intracranial or leptomeningeal metastases
- •Prior resection or radiotherapy for intracranial metastases allowed if the following criteria are met:
- •No active disease on 2 MRIs done one month apart
- •No requirement for anticonvulsant medications or steroids
- •Adequate pulmonary reserve to tolerate pneumonectomy:
- •Oxygen consumption greater than 50% predicted AND
- •FEV1 and DLCO greater than 80% predicted OR
- •FEV1 or DLCO less than 80% predicted allowed if postoperative FEV1 and DLCO is at least 40% predicted on the basis of split function V/Q scan
- •Prior radiotherapy to chest allowed provided 6 months have elapsed since completion of treatment and no history of, nor current evidence of, interstitial lung disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •WBC greater than 3,500/mm^3
- •PT/PTT normal
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •AST/ALT less than 1.5 times ULN
- •Creatinine less than 1.6 mg/dL
- •Cardiovascular:
- •Fixed defects on thallium scanning with ejection fraction greater than 40% allowed
- •Reversible or ischemic defects allowed only after cardiology clearance
- •See Disease Characteristics
- •Resting oxygen saturation greater than 90%
- •pCO_2 less than 45 mmHg by arterial blood gas
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infections
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •More than 30 days since prior biologic therapy for this malignancy
- •Chemotherapy:
- •More than 30 days since prior chemotherapy for this malignancy
- •Prior paclitaxel allowed
- •No prior bleomycin, nitrosoureas, or busulfan
- •Endocrine therapy:
- •See Disease Characteristics
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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