NCT00242762已完成2 期
A Phase II Study to Evaluate the Safety and Efficacy of the Combination of ZD1839 (IRESSA™), Docetaxel and Cisplatin in Subjects With Recurrent and/or Metastatic Head and Neck Cancer
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
- 36
- 试验地点
- 5
- 主要终点
- Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
研究概览
简要总结
The primary objective of the study is to evaluate the activity of the combination ZD1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response [CR] and partial response [PR]) at study closure.
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
- •Male or female, aged 18 and 70 years, inclusive
- •Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN
- •Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx
- •At least one uni-dimensionally measurable lesion according to the RECIST
- •World Health Organisation (WHO) performance status (PS) of 0 or 1
- •No previous chemotherapy for recurrent or metastatic disease
- •Before subject registration a quality of life questionnaire should be completed
排除标准
- •Previous chemotherapy for recurrent or metastatic disease
- •Less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy
- •Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- •Known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
- •Absolute neutrophil count (ANC) less than 1.5 x109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 10 g/dl
- •Serum bilirubin greater than the upper limit of the reference range (ULRR)
- •Serum creatinine greater than 1.5 mg/dl despite adequate rehydration
- •Creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR or alkaline phosphatase (ALP) greater than 2.5 times the ULRR
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- •Pregnancy or breast feeding (women of child-bearing potential)
- •Concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or St John's Wort
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- •Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded
结局指标
主要结局
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
次要结局
- PFS
- Overall survival
- Incidence of DLT during the first cycle of study treatment
- Nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
研究者
研究点 (5)
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