NCT00004930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
- 4
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.
PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung.
- Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population.
- Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
- Obtain preliminary evidence of therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period.
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 confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery
- •Bronchoalveolar cell lung cancer allowed
- •Lung metastases from soft tissue sarcoma allowed
- •No leukemia or lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 160,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.0 mg/dL
- •AST/ALT less than 1.5 times upper limit of normal
- •Creatinine no greater than 1.2 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •LVEF normal by MUGA scan or echocardiography
- •No unstable angina
- •No congestive heart failure
- •No symptomatic arrhythmias
- •DLCO at least 65% of normal
- •FVC at least 50% predicted
- •FEV1 at least 50% predicted
- •Resting oxygen saturation at least 90%
- •Exercise oxygen saturation at least 85%
- •No complete atelectasis
- •No asthma
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal
- •No other concurrent illness that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •No prior bleomycin or nitrosoureas
- •No prior mitomycin greater than 25 mg/m^2
- •No prior anthracyclines greater than 450 mg/m^2
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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