A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
详细描述
PRIMARY OBJECTIVES:
I. Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
II. Determine the response rate in patients with measurable disease treated with this drug.
III. Determine the frequency and severity of toxic effects of this drug in these patients.
IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant pleural mesothelioma
- •Epithelial
- •Sarcomatous
- •Measurable or nonmeasurable disease
- •Not amenable to extrapleural pneumonectomy
- •No known CNS metastases
- •Performance status - Zubrod 0-1
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)
- •Creatinine no greater than 2 times ULN
- •No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- •No active peptic ulcer disease
- •No intractable nausea or vomiting
- •Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
- •No known history of the following:
- •Dry eye syndrome
- •Sjogren's syndrome
- •Keratoconjunctivitis sicca
- •Exposure keratopathy
- •Fuch's dystrophy
- •Other active disorders of the cornea
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No HIV-positive patients receiving combination antiretroviral therapy
- •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission
- •No prior biologic therapy for this tumor
- •No prior chemotherapy for this tumor
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
- •Recovered from prior surgery
- •No prior surgical procedures affecting absorption
- •No prior investigational anticancer agents for this tumor
排除标准
- 未提供
研究组 & 干预措施
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Overall survival rate
时间窗: 1 year
Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.
RECIST response rate
时间窗: Up to 3 years
Association between EGFR expression with survival and response
时间窗: Up to 3 years
次要结局
未报告次要终点