NCT00290719终止1 期
A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pathological response (complete and partial) post-operatively
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 cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluate the pathologic response (complete and partial) in patients with resectable esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib, cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection.
Secondary
- Assess the safety and toxicity of this regimen in these patients.
- Evaluate objective tumor response in patients treated with this regimen.
- Determine the rate of complete resection in patients treated with this regimen.
- Determine surgical morbidity and mortality in 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 confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus
- •AC of the gastroesophageal junction allowed
- •Tumor must be considered surgically resectable (T1-3, NX)
- •No early-stage cancer (T1, N0)
- •The following lymph node (LN) criteria are considered acceptable:
- •Regional thoracic LN metastases (N1)
- •LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan
- •Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan
- •No distant metastases (M0)
- •PATIENT CHARACTERISTICS:
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Creatinine clearance ≥ 50 mL/min
- •Creatinine serum level ≤ CTC grade 2
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST < 3 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No known severe hypersensitivity to gefitinib or any of its excipients
- •No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease
- •No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina
- •No New York Heart Association class III or IV heart disease
- •No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
- •No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation
- •No evidence of any significant clinical disorder or laboratory finding that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy for esophageal cancer
- •No prior radiotherapy that would overlap the study treatment fields
- •Recovered from prior major surgery
- •No nonapproved or investigational drugs within the past 30 days
- •No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
排除标准
- 未提供
结局指标
主要结局
Pathological response (complete and partial) post-operatively
次要结局
- Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment
- Safety and toxicity post-operatively
- Response rate 2 weeks into treatment, pre-operatively, and post-operatively
- Completeness of resection post-operatively
- Surgical morbidity and mortality post-operatively
研究者
研究点 (1)
Loading locations...
相似试验
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
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
3 期
Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After ChemotherapyAdenocarcinoma of the Gastroesophageal JunctionEsophageal CancerNCT01243398University of Oxford450