NCT00234416已完成1 期
A Trial to Evaluate ZD1839 (IRESSA) in Combination With Radiotherapy & Gemcitabine as First-Line Treatment in Patients With Locally Advanced Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Incidence of DLT
研究概览
简要总结
The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays [Gy]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pancreatic cancer (aspiration biopsy by fine needle [PAAF] by USE or biopsy guide by ECO-CT). It is mandatory the diagnostic by USE and will recommend the aspiration biopsy with this technique
- •Tumoural volume by TAC < 500 cc
- •Aged 18 to 75 years inclusive
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) £ 1
- •Life-expectancy of more than 12 weeks
- •Women of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy
排除标准
- •Previous radiotherapy or chemotherapy for malignant disease
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •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)
- •Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 9 mg/dL; Prothrombin time (PT) less than 50%; Serum bilirubin greater than 2.5 times the upper limit of reference range (ULRR; Creatinine clearance less than 45 mL/min; ALT or AST greater than 2.5 times the ULRR
- •Active dermatoses (e.g. psoriasis, eczema)
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or drugs with known corneal toxicity
- •Known, severe hypersensitivity to ZD1839 or any of the excipients of this product
结局指标
主要结局
Incidence of DLT
次要结局
- Overall objective tumour response (CR and PR) based on the Response Evaluation Criteria in Solid Tumours (RECIST), assessed by abdominal CT (abdominal scan)
- Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
研究者
研究点 (2)
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