NCT00053300已完成2 期
Phase II Trial of Daily Thalidomide in Extensive Stage Small Cell Lung Cancer Patients Achieving a Complete or Partial Response to Induction Chemotherapy
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
- 2
- 主要终点
- Disease response
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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:
- •Diagnosis of extensive-stage small cell lung cancer
- •Complete or partial response after 4-6 courses of induction chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study
- •No greater than grade 1 peripheral neuropathy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Disease response
时间窗: every 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix CancerCarcinoma of the AppendixColorectal CancerNCT00310076Wake Forest University Health Sciences29
已完成
1 期
Thalidomide and Docetaxel in Treating Patients With Advanced CancerCancerNCT00049296Case Comprehensive Cancer Center26
已完成
2 期
S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple MyelomaMultiple MyelomaNCT00040937SWOG Cancer Research Network147
已完成
2 期
Thalidomide in Treating Patients With HIV-Associated Kaposi's SarcomaSarcomaNCT00019123National Cancer Institute (NCI)
已完成
2 期
Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian CancerOvarian CancerNCT00016224Memorial Sloan Kettering Cancer Center