NCT00524017已完成2 期
Phase II Study of Single-Agent Cetuximab for Treatment of High-Risk Pre-malignant Upper Aerodigestive Lesions
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins10 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2007年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- Number of Participants With Objective Response Based on Histologic Grade
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them.
PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating patients with precancerous lesions of the upper aerodigestive tract.
详细描述
OBJECTIVES:
Primary
- To determine the histologic response rate in patients with high-risk, premalignant lesions of the upper aerodigestive tract treated with cetuximab.
Secondary
- To determine the clinical response rate in these patients.
- To determine if patterns of epidermal growth factor receptor (EGFR) component expression are altered in these patients.
- To determine the change in status of genetic alterations, including loss of heterozygosity, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 high-risk, premalignant lesions of the upper aerodigestive tract, meeting one of the following criteria:
- •Unresectable, diffuse high-grade dysplasia, defined as moderate or severe dysplasia that is not assessable by physical examination and/or that cannot be excised by standard surgical techniques
- •previously treated HNSCC with persistent or recurrent high grade dysplasia with no evidence of head and neck malignancy for three months prior to enrollment or who have successfully completed therapy for head and neck malignancy more than 3 months prior to enrollment.
- •Dysplastic lesions with 3p or 9p loss of heterozygosity
- •Disease location amenable to endoscopic biopsy in an outpatient clinical setting or operative biopsy within the routine scheduling and practice of clinical care
- •No medical contraindication to biopsy of the target lesion
- •Pathology must be reviewed by the Johns Hopkins Hospital Department of Pathology
- •PATIENT CHARACTERISTICS:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Absolute neutrophil count (ANC) > 1,000/mm³
- •Platelet count > 75,000/mm³
- •Creatinine clearance > 60 mL/min
- •Total serum bilirubin < 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •No concurrent illness likely to preclude study therapy or surgical resection
- •Patients with a history of a curatively treated malignancy are eligible provided they are disease-free and have a survival prognosis that exceeds 5 years
- •No evidence of clinically active interstitial lung disease
- •Patients with chronic, stable radiographic changes who are asymptomatic are eligible
- •No history or radiological evidence of pulmonary fibrosis
- •No acute myocardial infarction within the past 3 months
- •No uncontrolled angina, arrhythmia, or congestive heart failure
- •No evidence of other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •No evidence of any other significant clinical disorder or laboratory finding that would preclude study participation
- •No known severe hypersensitivity to cetuximab or any of its excipients
- •No prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy
- •No severe abnormality of the cornea
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior oncologic or other major surgery or biopsy
- •More than 30 days since prior non-approved or investigational drugs
- •No prior chemotherapy, radiotherapy, or surgery for the premalignant lesions
- •No prior EGFR-targeted agents (e.g., cetuximab, gefitinib, or erlotinib)
排除标准
- 未提供
研究组 & 干预措施
Arm II (control)
No Intervention
Patients receive regular follow-up care
Arm I (treatment)
Experimental
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.
干预措施: cetuximab (Biological)
结局指标
主要结局
Number of Participants With Objective Response Based on Histologic Grade
时间窗: 8 weeks
Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).
次要结局
- Survival(Up to year 5 years post-treatment)
- Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies(Baseline (pre-treatment))
- Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies(At 8 weeks post-treatment)
- Lesion Recurrence(Up to year 5 years post-treatment)
- Number of Participants With Objective Response Based on Clinical Assessment(8 weeks)
研究者
研究点 (10)
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