NCT00188617已完成2 期
Phase II Study Of Single Agent Gefitinib (Iressa) In Patients With Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) Proceeding To Mediastinoscopy And Surgery
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- · To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
研究概览
简要总结
ELIGIBILITY
- Non-small cell lung cancer Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)* or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).
- Must be deemed appropriate surgical candidate
- ECOG performance status £ 2
- Age ³ 18 years
- No prior chemotherapy, radiotherapy or EGFR inhibitors
PRE-TREATMENT INVESTIGATIONS
- History, physical examination, hematology, biochemistry, toxicity/baseline symptoms: within 7 days of registration
- Radiology: CT chest within 7 days of registration
- Tumor biopsy prior to treatment
TREATMENT
- Gefitinib 250 mg will be administered orally daily x 28 days
EVALUATIONS ON TREATMENT
- Physical examination (vital signs, weight, ECOG performance status) weekly x 4
- Hematology (CBC, differential): Day 1,15, 29
- Biochemistry (creatinine, electrolytes, bilirubin, alkaline phosphatase, AST/ALT, protein): Day 1,15, 29
- Radiology: CT at baseline and after day 28
- Toxicity evaluation: continuous
DURATION OF TREATMENT
- Treatment is to be discontinued in cases of serious or unacceptable toxicity, or by patient or physician request
- Otherwise duration of therapy will be a maximum of 28 days
详细描述
Primary and Secondary Outcomes:
-
Objectives:
-
To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
-
To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A & 1B NSCLC
-
Enrollment
Treatment will be administered on an outpatient basis. Patients may be identified by thoracic surgeons, respirologists and/or interventional chest radiologists for study participation upon clinical and radiographic assessment.
**Diagnostic biopsy, Pretreatment Investigations
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
- •Patients must have biopsy-proven non-small cell lung carcinoma (NSCLC) or a lung nodule seen on CT imaging and a high-clinical suspicion of NSCLC
- •Clinical Stage 1A (T1N0M0 a tumor that is 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, and without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e., not in the main bronchus)
- •or 1B (T2N0M0 a tumor with any of the following features of size or extent: More than 3 cm in greatest dimension. Involves the main bronchus, 2 cm or more distal to the carina. Invades the visceral pleura. Associated with atelectasis or obstructive pneumonitis that extends to the hilar region but does not involve the entire lung).
- •Must be deemed appropriate surgical candidate
- •ECOG performance status £ 2
- •Age ³ 18 years
- •No prior chemotherapy, radiotherapy or EGFR inhibitors
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have received prior anticancer treatment with chemotherapy, radiotherapy or EGFR inhibitor therapy;
- •Patients who have had a previous diagnosis of cancer, are excluded except if have been adequately treated for non-melanoma skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given.
- •Patients may not be receiving any other investigational or anticancer agents while on study;
- •History of allergic reactions to Gefitinib or erlotinib
- •Pre-existing diarrhea ³ NCI CTC Grade 2
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g. Sjogrens etc.) or gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis) or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women because of the unknown effects of Gefitinib on the human fetus.
- •HIV-positive patients on active treatment
- •Active malignancy at any other site including combined small cell and non-small cell carcinomas or a pulmonary carcinoid tumor.
- •Taking drugs that induce CYP3A4 enzymes, patients with ongoing use of phenytoin, rifampicin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded.
- •Incomplete healing from previous surgery.
- •Use of any agent that decreases gastric pH, including proton pump inhibitors, Histamine-2 receptor blockers or sodium bicarbonate. Use of calcium or magnesium based elixirs are not included.
结局指标
主要结局
· To assess the pathologic and radiological response rate after neoadjuvant Gefitinib treatment
时间窗: before starting drug and after 28 days of treatment
次要结局
- · To assess the toxicity of neoadjuvant Gefitinib treatment in clinical stage 1A & 1B NSCLC(at baseline, 2weeks into treatment at 4weeks and 30 days after stopping drug)
研究者
研究点 (2)
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