NCT00054392撤回3 期
A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 113
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.
- Compare the overall response rate and time to progression in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.
- Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.
In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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) of 1 of the following types:
- •Squamous cell
- •Adenocarcinoma
- •Large cell anaplastic
- •Bronchoalveolar
- •Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)
- •Evidence of at least 1 of the following:
- •Clinically documented recurrent disease after prior radiation or surgery
- •Stage IV disease (distant metastases)
- •Stage IIIB disease presenting with 1 of the following:
- •Pleural or pericardial effusion by CT scan or chest x-ray
- •Pleural implants documented pathologically or seen on CT scan or x-ray
- •Measurable or evaluable disease
- •No brain metastases unless clinically stable after surgery and/or radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST less than 5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 40 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for advanced NSCLC
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
- •No concurrent radiotherapy (except for brain metastases)
- •See Disease Characteristics
- •No concurrent aminoglycoside antibiotics
排除标准
- 未提供
结局指标
主要结局
Survival
次要结局
- Tumor response rate
- Time to disease progression
- Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter
研究者
研究点 (113)
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