NCT00025207已完成2 期
A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of patients who remain failure-free
研究概览
简要总结
Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma
详细描述
OBJECTIVES:
I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma.
II. Determine the response rate in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the overall survival of patients treated with this drug. V. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
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
- •Histologically confirmed malignant mesothelioma that is not amenable to curative surgery or radiotherapy
- •Epithelial, sarcomatoid, or mixed subtype
- •Any site of origin (including, but not limited to, the pleura, peritoneum, pericardium, or tunica vaginalis) allowed
- •Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter) as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- •Must be outside prior radiation port
- •Lesions not considered measurable include the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No known brain metastases
- •Performance status - CTC 0-1
- •Granulocyte 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 no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other concurrent active malignancy except nonmelanoma skin cancer
- •Disease considered not currently active if completely treated with less than a 30% risk for relapse
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No prior epidermal growth factor receptor-inhibitor therapy
- •Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed
- •No prior systemic cytotoxic chemotherapy for malignant mesothelioma
- •No concurrent chemotherapy
- •At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone)
- •No concurrent CYP3A4 inducers (e.g., dexamethasone)
- •No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for non disease-related conditions (e.g., insulin for diabetes)
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy, including for palliation
- •See Disease Characteristics
- •At least 2 weeks since prior major surgery
- •At least 1 week since other prior CYP3A4 inducers (e.g., carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, St. John's Wort, sulfadimidine, sulfinpyrazone, or troglitazone)
- •No other concurrent CYP3A4 inducers
- •No concurrent CYP3A4 substrates or inhibitors
- •No other concurrent investigational agent
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent chlorpromazine, amiodarone, or chloroquine
排除标准
- 未提供
研究组 & 干预措施
Treatment (gefitinib)
Experimental
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: gefitinib (Drug)
Treatment (gefitinib)
Experimental
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks 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
Percentage of patients who remain failure-free
时间窗: Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months
Kaplan-Meier's product limit estimator and curves will be used.
次要结局
- Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0(Up to 4 years)
- Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression(Up to 4 years)
- Overall survival(Up to 4 years)
- Tumor response rate(Up to 4 years)
研究者
研究点 (1)
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