NCT00020124已完成1 期
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
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. Giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetic profile of inhaled doxorubicin in blood 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.
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 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 proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery
- •Clinical evidence of primary lung or tracheal cancer OR
- •Metastatic cancer to the lung
- •Extrathoracic metastases eligible if following criteria are met:
- •Sites are stable
- •Pulmonary sites are primary life-threatening sites
- •Evidence that study treatment may benefit the patient
- •Measurable or evaluable disease
- •No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents
- •No complete atelectasis due to high-grade airway obstruction
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.0 mg/dL
- •AST and ALT less than 1.5 times upper limit of normal
- •Creatinine no greater than 1.6 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •LVEF at least 40% by MUGA scan or echocardiogram
- •No unstable angina, congestive heart failure, or symptomatic arrhythmias
- •DLCO at least 50% predicted
- •FVC and FEV1 at least 50% predicted
- •Resting oxygen saturation at least 90%
- •Exercise oxygen saturation at least 85%
- •Oxygen consumption greater than 50% predicted
- •No prior radiation pneumonitis
- •No asthma
- •No radiation-induced pulmonary damage
- •No hypersensitivity to doxorubicin
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •HIV negative
- •No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy and recovered
- •No prior trastuzumab (Herceptin)
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram
- •No prior mitomycin, bleomycin, or nitrosoureas
- 另有 14 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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