NCT00079287已完成3 期
Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Japan Multinational Trial Organization48 个研究点 分布在 1 个国家开始时间: 2001年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 48
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel, paclitaxel, and carboplatin, work in 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 combination chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the therapeutic effect of vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin in patients with advanced non-small cell lung cancer.
- Compare the overall survival of patients treated with these regimens.
Secondary
- Compare the response rate in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
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 or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:
- •Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
- •Newly diagnosed stage IV disease
- •Recurrent disease after prior surgery and/or radiotherapy
- •The following cellular subtypes are allowed:
- •Adenocarcinoma
- •Large cell carcinoma
- •Squamous cell carcinoma
- •Unspecified carcinoma
- •Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy
- •Pleural effusions, ascites, and laboratory parameters are not allowed as the only evidence of disease
- •Disease must be present outside area of prior surgical resection
- •Disease must be present outside area of prior radiotherapy OR new lesion documented
- •No known brain metastases by CT scan or MRI within the past 6 weeks
- •No pleural or pericardial effusions requiring treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •SGOT or SGPT ≤ 2 times ULN
- •Alkaline phosphatase ≤ 2 times ULN
- •Creatinine ≤ ULN
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina
- •No congestive heart failure
- •No myocardial infarction within the past year
- •No ventricular arrhythmia requiring medical intervention
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior allergic drug reaction attributed to Cremophor or polysorbate 80
- •No disorder associated with lung cancer with life-threatening consequences
- •No motor or sensory neuropathy ≥ grade 2
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
- •No uncontrolled diabetes
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for NSCLC
- •Chemotherapy
- •No prior systemic chemotherapy for NSCLC
- •Endocrine therapy
- 另有 10 项未显示
排除标准
- 未提供
研究者
研究点 (48)
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