NCT01024712Unknown2 期
Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Overall-response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with gefitinib and to see how well it works in treating patients with Stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and carboplatin in combination with intermittent gefitinib in patients with advanced nonsquamous non-small cell lung cancer.
Secondary
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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)
- •No squamous cell carcinoma
- •Untreated Stage IIIB or IV disease not suitable for surgery or radiotherapy OR patients with postoperative recurrence who had never been treated by chemotherapy
- •No history of smoking or light smoking (< 10 packs a year and smoking abatement ≥ 15 years)
- •At least 1 measurable tumor mass (length > 1.5 cm and width > 1.0 cm)
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Absolute neutrophil count ≥ 2 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •ALT and AST ≤ 1.5 times upper limit of normal (ULN)
- •Total bilirubin ≤1.5 times ULN
- •Serum creatinine normal
- •Creatinine clearance ≥ 50 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignant tumors within the past year except for basal cell or squamous cell carcinoma of the skin, or in situ malignant cancer that has been completely resected
- •No history of allergic reaction to any component of the drugs in this study
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 1 month since prior investigational drugs or medical devices
- •No prior chemotherapy or radiotherapy for this tumor
- •No concurrent liposomal paclitaxel
- •No other concurrent antitumor therapy (e.g., radiotherapy or surgical treatment)
- •No other concurrent anticancer chemotherapy drugs or anticancer Chinese herbs
排除标准
- 未提供
结局指标
主要结局
Overall-response rate
次要结局
- Disease-control rate
- Safety
- Quality of life
- Progression-free survival
- Overall survival
研究者
研究点 (1)
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