NCT00075426已完成2 期
A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
Secondary
- Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
- Determine the patterns of failure and survival in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 non-small cell lung cancer (NSCLC), meeting criteria for 1 of the following:
- •Locally advanced disease not amenable to radiotherapy or surgery
- •Metastatic disease
- •Received at least 1 course of platinum-based (e.g., cisplatin or carboplatin) chemotherapy
- •No uncontrolled central nervous system (CNS) metastases
- •Ineligible for higher priority treatment protocols
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-1 OR
- •Zubrod Scale 0-1 OR
- •South West Oncology Group (SWOG) 0-1
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •Serum glutamate oxaloacetate transaminase (SGOT) and Serum glutamate pyruvate transaminase (SGPT) no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •Calcium no greater than 12 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No uncontrolled, clinically significant dysrhythmia
- •Cardiac ejection fraction greater than 50%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Electrolytes (including magnesium) normal
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No prior or ongoing peripheral neuropathy grade 2 or greater
- •No other medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent cytokine therapy
- •Chemotherapy
- •See Disease Characteristics
- •No more than 2 prior chemotherapy regimens for NSCLC
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 2 weeks since prior radiotherapy
- •No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- •No concurrent radiotherapy
- •Concurrent palliative or emergent radiotherapy allowed
- •More than 2 weeks since prior surgery
- •At least 4 weeks since prior antineoplastic agents for non-malignant conditions (e.g., methotrexate for rheumatoid arthritis)
- •No concurrent antineoplastic agents for non-malignant conditions
排除标准
- 未提供
研究者
研究点 (1)
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