NCT00093652终止1 期
ZD1839 (IRESSA®) With Oxaliplatin and Radiotherapy for Esophageal Carcinoma. A Phase I/II Study With Biologic Correlates
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic esophageal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oxaliplatin when administered with gefitinib and radiotherapy in patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II)
Secondary
- Determine time to tumor progression and median survival in patients treated with this regimen.
- Determine quality of life in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction
- •Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound
- •Stage T2, N0 disease and beyond
- •Bulk of tumor must be in the esophagus of patients with GE junction tumor
- •Bronchoscopy is required if primary esophageal tumor is < 26 cm from the incisors
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin normal
- •ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Not specified
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No clinically active interstitial lung disease
- •Patients with chronic stable asymptomatic radiographic changes are eligible
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
- •No peripheral neuropathy ≥ grade II
- •No severe hypersensitivity to gefitinib or any of its excipients
- •No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy
- •No active or ongoing infection
- •No other uncontrolled illness
- •No other significant clinical disorder or laboratory finding that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent colony-stimulating factors during course 1 of study therapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy
- •Concurrent steroid therapy allowed
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Not specified
- •More than 30 days since prior non-approved or investigational drugs
- •No concurrent administration of any of the following:
- •Phenytoin
- •Carbamazepine
- •Barbiturates
- •Highly-active antiretroviral therapy (HAART)
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (phase I)
Response (phase II)
次要结局
- Safety and toxicity
- Immunohistochemistry
- Survival
- Quality of life
研究者
研究点 (1)
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