NCT00217698已完成2 期
Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 28
- 主要终点
- Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine 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 more than one drug (combination chemotherapy) may kill more tumor cells. Giving gefitinib as first-line therapy followed by gemcitabine and cisplatin after disease progression may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well gefitinib works as first-line therapy followed by gemcitabine and cisplatin in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of gefitinib as first-line therapy, in terms of response rate (complete and partial response) or stability of disease, in patients with de novo or recurrent stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the safety of this drug in these patients.
- Determine the efficacy of gemcitabine combined with cisplatin when administered after first-line gefitinib in these patients.
- Determine quality of life of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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), including any of the following cellular subtypes:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Large cell carcinoma
- •Poorly differentiated NSCLC NOTE: *New biopsies or cytologic specimens required for primary resection specimens older than 2 years
- •De novo or recurrent disease, meeting 1 of the following stage criteria:
- •Stage IIIB disease
- •Malignant pleural effusion OR supraclavicular node involvement (N3)
- •Not suitable for curative multimodal treatment or surgery
- •Stage IV disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
- •Measurable lesion must be outside previously irradiated areas
- •Immediate chemotherapy is not clinically mandatory
- •No small cell lung cancer (SCLC) or SCLC combined with NSCLC
- •No symptomatic and/or untreated brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10.0 g/dL
- •Bilirubin normal
- •AST or ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of bone metastases)
- •No unstable or uncompensated hepatic disease
- •Creatinine clearance > 60 mL/min
- •No unstable or uncompensated renal disease
- •Cardiovascular
- •No unstable or uncompensated cardiac disease
- •No myocardial infarction within the past 3 months
- •No clinically active interstitial lung disease
- •Asymptomatic patients with chronic stable radiographic changes allowed
- •No unstable or uncompensated respiratory disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- •Able to swallow and retain oral medication
- •No active infection
- •No uncontrolled diabetes mellitus
- •No history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to study drugs
- •No other severe or uncontrolled systemic disease
- •No other serious underlying medical condition that would preclude study participation
- •No psychiatric disability that would preclude study compliance or giving informed consent
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment
次要结局
- Disease stabilization (CR, PR, or SD) after 6 and 18 weeks of study treatment
- Objective response (CR and PR) to gefitinib treatment after weeks 6, 12, and 18
- Adverse reactions to gefitinib treatment measured after completion of study treatment
- Time to progression (TTP) with gefitinib treatment after completion of study treatment
- Event-free survival (EFS) with gefitinib treatment after completion of study treatment
研究者
研究点 (28)
Loading locations...
相似试验
已完成
2 期
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00411047Massachusetts General Hospital34
终止
2 期
Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone TherapyProstate CancerNCT00483561University of Nebraska26
已完成
2 期
Gefitinib in Treating Patients With Locally Advanced Esophageal CancerEsophageal CancerNCT00100945Alliance for Clinical Trials in Oncology70
终止
2 期
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By SurgeryEsophageal CancerNCT00258297University of Rochester30
撤回
1 期
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT00268255Barbara Ann Karmanos Cancer Institute