NCT00096031已完成2 期
Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 152
- 主要终点
- Overall Survival at 6 Months
研究概览
简要总结
RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
- Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
- Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.
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 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 of 1 of the following sites:
- •Thoracic esophagus, located > 20 cm* from the incisors
- •Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors located < 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
- •Disease confined to the esophagus and periesophageal soft tissue
- •Metastatic disease
- •Measurable disease by x-ray, scanning, or physical examination
- •Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease
- •One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Not specified
- •Creatinine ≤ 1.5 times upper limit of normal
- •No prior allergic reaction to chimerized or murine monoclonal antibodies
- •No evidence of human anti-mouse antibodies (HAMA)
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior cetuximab
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy and recovered
- •At least 3 weeks since prior thoraco-abdominal surgery and recovered
- •No other prior therapy that specifically targets the epidermal growth factor pathway
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Cetuximab
Experimental
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
干预措施: cetuximab (Biological)
结局指标
主要结局
Overall Survival at 6 Months
时间窗: every 3 weeks while on treatment, then every 3 months
Time to death is measured from date of registration to date of death due to any cause.
次要结局
- Time to Progression(every 3 weeks while on treatment, then every 3 months for 3 years)
- Time to Treatment Failure(every 3 weeks while on treatment)
研究者
研究点 (152)
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