NCT00087048终止2 期
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride.
Secondary
- Determine the safety and toxic effects of this drug in these patients.
- Determine the recurrence-free survival of patients treated with this drug.
- Determine time to response and tumor response in patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
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:
- •Histologically confirmed small cell lung cancer (SCLC)
- •Recurrent extensive stage disease
- •No mixed histology
- •Measurable disease
- •At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI
- •Sensitive disease
- •Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
- •Eligible for high-dose chemotherapy
- •No symptomatic brain metastases affecting performance status
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Hematocrit > 35% (without transfusion)
- •Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal*
- •Alkaline phosphatase ≤ 2 times normal*
- •Bilirubin ≤ 2.0 mg/dL
- •Albumin > 2.5 g/dL
- •Hepatitis B surface antigen negative
- •No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present
- •Creatinine clearance ≥ 40 mL/min
- •Cardiovascular
- •No history of cardiac arrhythmias
- •No congestive heart failure
- •No ischemic heart disease
- •No stroke or other embolic disease requiring daily treatment that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •HIV negative
- •No known seizure disorder
- •No active infection requiring systemic therapy within the past 2 weeks
- •No known hypersensitivity to topotecan hydrochloride
- •No medical or psychiatric condition that would preclude study participation
- •No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
- •No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
- •No prior topotecan hydrochloride
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Recurrence-free survival
- Safety and toxic effects
- Time to response and tumor response
- Quality of life
研究者
研究点 (2)
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