NCT00281970已完成2 期
Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-small Cell Lung Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Total cisplatin dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer.
Secondary
- Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Pathologically proven non-small cell lung cancer (NSCLC)
- •Stage IA-IIIB disease
- •Underwent prior complete surgical resection (R0) no more than 2 months ago
- •Eligible for cisplatin-based adjuvant chemotherapy
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status ≥ 70%
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Creatinine clearance > 55 mL/min
- •Total bilirubin normal
- •Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria:
- •Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- •AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- •AP ≤ 5 times ULN AND AST and ALT normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No peripheral neuropathy > grade 1
- •No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior postoperative radiation therapy
- •No prior chemotherapy for NSCLC
- •No prior docetaxel or cisplatin
- •No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim
排除标准
- 未提供
结局指标
主要结局
Total cisplatin dose
次要结局
- Toxicity
- Overall survival
- Disease-free survival
研究者
研究点 (3)
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