NCT00182806已完成2 期
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Objective response (complete, partial, and stable disease)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine.
Secondary
- Determine the median time to progression in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- •Stage IIIA or IIIB disease
- •Progressive disease
- •Stage IV disease
- •Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
- •Measurable or evaluable disease, as defined by 1 of the following criteria:
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- •Lesions apparent on CT scan that do not meet the criterion for measurability
- •Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST and ALT ≤ 1.5 times normal
- •Alkaline phosphatase < 1.5 times normal
- •Bilirubin ≤ 1.3 mg/dL
- •Creatinine ≤ 1.6 mg/dL OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No unstable angina
- •No congestive heart failure
- •No myocardial infarction within the past 3 months
- •No life-threatening ventricular arrhythmia requiring maintenance therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- •No uncontrolled seizure disorder
- •No uncontrolled diabetes mellitus
- •No active infection requiring systemic therapy
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other unstable or serious condition
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy
- •Prior irinotecan allowed
- •No prior gemcitabine
- •No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response (complete, partial, and stable disease)
次要结局
- Median time to progression
研究者
研究点 (2)
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