NCT00132054已完成1 期
Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
Japan Multinational Trial Organization14 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 14
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the frequency and severity of adverse events in patients treated with this regimen.
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 small cell lung cancer
- •Extensive stage disease
- •Recurrent or relapsed disease after 1-2 prior chemotherapy and/or radiotherapy regimens
- •No unmanageable massive pleural effusion or pericardial effusion by chest CT scan
- •No symptomatic brain metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •ALT and AST ≤ 2 times upper limit of normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine normal
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina
- •No congestive heart failure
- •No myocardial infarction within the past year
- •No ventricular arrhythmia requiring medical intervention
- •No other serious cardiovascular disease
- •Arterial oxygen pressure (PaO_2) ≥ 70 torr
- •No interstitial pneumonitis or pulmonary fibrosis by chest x-ray
- •Gastrointestinal
- •No serious diarrhea
- •No paralytic or obstructive ileus
- •Not pregnant or nursing
- •No uncontrolled diabetes
- •No severe infectious disorder
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior anthracycline or its derivatives at > the upper dose limit (e.g., daunorubicin ≥ 25 mg/kg, doxorubicin ≥ 500 mg/m^2, or epirubicin ≥ 900 mg/m^2)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •Not specified
排除标准
- 未提供
研究者
研究点 (14)
Loading locations...
相似试验
已完成
2 期
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung CancerLung CancerNCT00104793Japan Multinational Trial Organization55
已完成
1 期
Irinotecan and Capecitabine in Treating Women With Advanced Breast CancerBreast CancerNCT00083148Roswell Park Cancer Institute12
已完成
2 期
Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00182806Roswell Park Cancer Institute38
已完成
2 期
Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing ChemotherapyColorectal CancerNCT01079780Eastern Cooperative Oncology Group136
已完成
1 期
Irinotecan and Celecoxib in Treating Patients With Unresectable or Metastatic Colorectal CancerDiarrheaColorectal CancerNCT00084721Roswell Park Cancer Institute2