NCT00079053已完成1 期
A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Recommended phase II dose at the end of course 1
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.
详细描述
OBJECTIVES:
Primary
- Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the head and neck.
- Determine the toxicity of this drug in these patients.
- Determine the effects of this drug on plasma and urinary angiogenic factors (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and basic fibroblast growth factor levels) in these patients.
- Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone.
- Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck
- •Stage III, IVA, or IVB
- •Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks
- •Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose
- •No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:
- •Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
- •Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
- •Tumor tissue samples available for EGFRvIII mutation analysis
- •No known brain metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •ALT/AST < 2 times upper limit of normal (ULN)
- •Bilirubin < ULN (unless due to Gilbert's syndrome)
- •Creatinine < 1.5 times ULN
- •Cardiovascular
- •No myocardial infarction within the past year
- •No cardiac ventricular arrhythmias requiring medication
- •No history of cardiac disease
- •No uncontrolled high blood pressure
- •No unstable angina
- •No congestive heart failure
- •No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
- •No severe exposure keratopathy
- •No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- •No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- •No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- •No congenital abnormality (e.g., Fuch's dystrophy)
- •No ocular inflammation or infection
- •Gastrointestinal
- •Able to take oral medication
- •No gastrointestinal (GI) tract disease requiring IV alimentation
- •No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
- •No active peptic ulcer disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No serious active infection
- •No other serious underlying medical condition that would preclude study participation
- •No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
- •No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Recommended phase II dose at the end of course 1
Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1
次要结局
- Disease-free survival
- Correlative studies (archival and prospective) at accrual completion
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube CancerFallopian Tube CancerPeritoneal Cavity CancerOvarian CancerNCT00217529Fred Hutchinson Cancer Center
已完成
2 期
Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by SurgeryBreast CancerNCT00633750Vanderbilt-Ingram Cancer Center50
已完成
2 期
S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung CancerLung CancerNCT00445848SWOG Cancer Research Network89
已完成
2 期
S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar CarcinomaLung CancerNCT00436332SWOG Cancer Research Network84
终止
不适用
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast CancerBreast CancerNCT00503841Barbara Ann Karmanos Cancer Institute44