NCT00114192已完成2 期
Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Complete and partial response rates
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the response duration and survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
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 or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
- •Stage IIIB (with pleural effusion)
- •Stage IIIA or IIIB
- •Previously treated and not eligible for surgery or definitive thoracic radiotherapy
- •Measurable or evaluable disease
- •Documented disease progression during or after standard first-line chemotherapy that may have included taxane
- •No untreated brain metastases
- •Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count > 100,000/mm^3
- •Bilirubin normal
- •SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
- •SGOT and/or SGPT normal AND alkaline phosphatase ≤ 4 times ULN AND no ascites
- •Albumin > 3.0 g/dL
- •Creatinine < 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception for 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- •No HIV positivity
- •No peripheral neuropathy > grade 1
- •No other malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- •No active infections
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
- •Prior neoadjuvant or adjuvant systemic chemotherapy allowed
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Recovered from prior radiotherapy
- •Not specified
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Complete and partial response rates
次要结局
- Survival
- Quality of life
- Toxicity
- Response duration
研究者
研究点 (1)
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