NCT00103051已完成2 期
Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家开始时间: 2004年12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
- 试验地点
- 1
- 主要终点
- Complete response rate as measured by RECIST criteria prior to surgery
研究概览
简要总结
RATIONALE: 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. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung cancer undergoing surgery.
Secondary
- Determine the safety profile of this regimen in these patients.
- Determine the stage downsizing and complete resectability rate in patients with no progressive disease who undergo surgery after treatment with this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary non-small cell lung cancer (NSCLC)
- •Clinical stage IIIA by chest CT scan
- •Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or video-assisted thoracic surgery
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Planning to undergo lobectomy or pneumonectomy after induction therapy
- •No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT scan or ultrasound of the liver and adrenal glands
- •No pleural or pericardial effusion
- •No superior vena cava syndrome
- •No diffuse interstitial pulmonary fibrosis
- •No signs or symptoms of CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin normal
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.25 times ULN
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No medically uncontrolled congestive heart failure or angina pectoris
- •No uncontrolled hypertension or arrhythmia
- •No myocardial infarction within the past year
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Physically and mentally fit to receive gemcitabine- and cisplatin-containing chemotherapy
- •Physiologically fit to undergo surgery
- •No uncontrolled, active infection requiring IV antibiotics
- •No history of hypersensitivity to gefitinib or any of its excipients
- •No motor or sensory neurotoxicity ≥ grade 2
- •No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- •No prior melanoma, breast cancer, or renal cell cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •No prior chemotherapy for NSCLC
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No concurrent antiestrogen therapy
- •Concurrent replacement steroids and antiemetic steroids allowed
- •Radiotherapy
- •No prior radiotherapy for NSCLC
- •See Disease Characteristics
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete response rate as measured by RECIST criteria prior to surgery
次要结局
- Toxicity as assessed by CTC
- Overall response rate as measured by RECIST criteria prior to surgery
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland TumorHead and Neck CancerNCT00079079NCIC Clinical Trials Group34
撤回
2 期
Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or CarboplatinFallopian Tube CancerPeritoneal Cavity CancerOvarian CancerNCT00369954Gynecologic Oncology Group
已完成
2 期
Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00326599Alliance for Clinical Trials in Oncology101
已完成
2 期
Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic CancerPancreatic CancerNCT00126633University of California, San Francisco53
已完成
2 期
Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the GallbladderExtrahepatic Bile Duct CancerGallbladder CancerNCT00084942Roswell Park Cancer Institute