NCT00258297终止2 期
A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
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. Giving gefitinib before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.
Secondary
- Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.
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 squamous cell or adenocarcinoma of the thoracic esophagus
- •Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
- •Stage I-III disease
- •No known distant metastases
- •No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
- •No supraclavicular metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Adequate bone marrow function
- •Adequate hepatic function
- •No unstable or uncompensated hepatic disease
- •Creatinine ≤ grade 2 by Common Toxicity Criteria
- •Adequate renal function
- •No unstable or uncompensated renal disease
- •Cardiovascular
- •No unstable or uncompensated cardiac disease
- •No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
- •No unstable or uncompensated respiratory disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No known hypersensitivity to gefitinib or any of the excipients
- •No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
- •No evidence of severe or uncontrolled systemic disease
- •No other significant clinical disorder or laboratory finding that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Endocrine therapy
- •Concurrent stable-dose steroids allowed
- •Recovered from any prior oncologic or other major surgery
- •More than 30 days since prior nonapproved or investigational drug
- •No prior therapy for this or any other malignancy
- •No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)
排除标准
- 未提供
结局指标
主要结局
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By SurgeryEsophageal CancerNCT00290719University of California, San Francisco6
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
Unknown
2 期
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung CancerLung CancerNCT00616499Yonsei University35
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
已完成
2 期
Gefitinib in Treating Patients With Locally Advanced Esophageal CancerEsophageal CancerNCT00100945Alliance for Clinical Trials in Oncology70