NCT01592383已完成2 期
Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations
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
- 2
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.
详细描述
PRIMARY OBJECTIVES:
I. To determine the objective response rate (complete response [CR] + partial response [PR]) of erlotinib in malignant peritoneal mesothelioma (MPeM) patients who have epidermal growth factor receptor (EGFR) mutations.
SECONDARY OBJECTIVES:
I. To determine the percentage of patients with MPeM who have EGFR mutations. II. To characterize asbestos exposure history and other clinical parameters of patients with MPeM who do or do not have EGFR mutations.
III. To determine the disease control rate (CR + PR + stable disease [SD]) of MPeM patients who have EGFR mutations and are treated with erlotinib.
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- or cytologically-confirmed malignant peritoneal mesothelioma; epithelial, sarcomatoid, biphasic, or well-differentiated papillary subtypes are allowed.
- •A tumor block or 10 unstained slides must be available for determining EGFR mutational status; only those patients who have a mutation of the EGFR tyrosine kinase domain will be able to enroll in this study.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan.
- •No prior use of EGFR tyrosine kinase inhibitors or monoclonal antibodies; all other prior treatments are allowed if >= 4 weeks since treatment completed, including chemotherapy (systemic or intraperitoneal), radiation therapy, and/or surgery; there is no limit on the number of previous treatments allowed.
- •Life expectancy of greater than 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Leukocytes >= 2,000/mcL.
- •Absolute neutrophil count >= 1,500/mcL.
- •Platelets >= 100,000/mcL.
- •Total bilirubin =< 1.5 X institutional upper limit of normal (ULN).
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional ULN.
- •Creatinine =< 2 X institutional ULN OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- •The effects of erlotinib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed screening and treatment consent.
排除标准
- •Chemotherapy, radiotherapy, or surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Patients may not be receiving any other investigational agents.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop. progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib.
- •EGFR-mutation negative tumor tissue as determined by sequencing; if an individual tissue test result is inconclusive (unable to be determined), it will be considered negative for study eligibility purposes.
- •History of previous malignancy excluding non-melanoma skin lesions and in-situ cervical cancer; patients with other malignancies are eligible if they have been disease free for >= 3 years.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because it is unknown if erlotinib poses a potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib, breastfeeding should be discontinued if the mother is treated with erlotinib.
- •Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with erlotinib; in addition, these patients are at increased risk of lethal infections; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- •Inability to tolerate or absorb an oral medication due to any cause, including but not limited to malabsorption syndromes.
研究组 & 干预措施
Treatment (enzyme inhibitor therapy)
Experimental
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 1 year
Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
次要结局
- OS(1 year)
- Toxicity(30 days from the last dose of study drug)
- Disease Control Rate - SD + PR + CR(1 year)
- EGFR Mutations Percentage(Baseline)
- PFS(1 year)
研究者
研究点 (1)
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