NCT01185158已完成2 期
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma
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
- 46
- 试验地点
- 1
- 主要终点
- To assess the activity of 250mg of ZD1839 administered as a single agent to patients with recurrent or metastatic or both recurrent and metastatic head and neck cancer.
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's squamous cell head and neck cancer. The research is being done because currently no effective treatment exists for metastatic (spread of cancer cells from one area of the body to another) or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 squamous cell carcinoma of the head and neck incurable by surgery or radiation
- •Patients must have measurable disease, defined as at least on e lesion that can be accurately measured in the one dimension (longer diameter to be recorded) as greater then or equal to 20mm with conventional techniques or as greater than or equal to 10mm with computed tomograpy (CT) scan.
- •Therapeutic history that includes the Following:
- •No prior EGFR-based therapy for recurrent disease
- •No chemotherapy or irradiation with the 28-day period preceding entry to the study
- •Eastern Cooperative Oncology Group (ECOG)performance Status 0-2 (kamofsky >59%)
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes >3,000ml
- •absolute neutrophil count 1,500/ml
- •platelets 100,000/ml
- •total bilirubin within normal institutional limits
- •AST(SGOT)ALT(SGPT) <2.5 X institutional upper limits of normal
- •Creatinine <1.5
排除标准
- •Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical in situ.
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, ketoconazole, erythromycin, clarithromycin, atorvastatin, cimetidine, ametidine, amitriptyline, imipramine, verpamil, tamoxifen, chlorpromazine, amiodorone, chloroquine, St. John's Wort
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •Incomplete healing from previous oncologic or other major surgery Patients may not be receiving any other investigational agents
- •History of allergic reactions attributed to compound of similar chemical or biologic composition to ZD 1839
- •Uncontrolled intercurrent illness
- •Pregnancy or breast feeding (women of child -bearing potential
研究组 & 干预措施
ZD1839 (IRESSA) 250mg
Experimental
ZD1839(IRESSA) 250mg orally (po) daily
干预措施: ZD1839 (IRESSA) (Drug)
结局指标
主要结局
To assess the activity of 250mg of ZD1839 administered as a single agent to patients with recurrent or metastatic or both recurrent and metastatic head and neck cancer.
时间窗: 2 -5 years
次要结局
- To demonstrate the effectiveness of ZD 1839 as an inhibitor of epithelial growth factor (EGFR) phosphorylation, MAP kinase activation, and vascular endothelial growth (VEGF) secretion in metastatic head and neck cancer.(2-5 years)
研究者
研究点 (1)
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