NCT00242749已完成2 期
A Phase 2 Trial to Evaluate ZD1839 (IRESSA) in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma (Unresectable &Inoperable)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Disease-free survival at 2 years
研究概览
简要总结
· To evaluate the disease free survival rate at 2 years of patients with advanced head and neck carcinoma treated with ZD1839 250 mg administered once daily in combination with cisplatin and a standard course of radiotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous head and neck carcinoma
- •Extra-laryngeal tumour or laryngeal tumour that is inoperable (not resectable) considered by Head and Neck Cancer Committee
- •Stage III-IV (IVa and IVb) disease
- •Measurable disease according to RECIST criteria
- •Aged 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- •Normal renal, haematological (neutrophils >1´5 x 109/ L and platelets > 100 x 109/L) and liver function
排除标准
- •Previous treatment for initial disease (neck dissection in N3 is allowed)
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Incomplete healing from previous oncologic or other surgery
- •Absolute neutrophil count (ANC) less than 1.5 x 109/ L, or platelets less than 100x 109/L
- •Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR)
- •In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •Serum creatinine greater than 1.25 times the ULRR
- •ALT or AST greater than 2.5 times the ULRR
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
- •Active dermatoses (e.g. psoriasis, eczema)
- •Corneal abnormalities (other than scars, congenital abnormality or corneal tear film), history of dry eye syndrome or ocular surface diseases and neurological disorders
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin or drugs with known corneal toxicity
- •Pregnancy or breastfeeding (women of child-bearing potential)
- •Patient incapacity to reliably follow the treatment or follow up for family, economic or geographical reasons.
结局指标
主要结局
Disease-free survival at 2 years
次要结局
- Objective tumour response (CR and PR) at 6 months after the start of treatment based on the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- PFS
- Nature, incidence and severity of adverse events (AEs)
- Overall survival
研究者
研究点 (4)
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