EUCTR2004-000358-21-CZ进行中（未招募）不适用
A Phase II Randomised, Double-blind, Placebo-controlled, Multicentre Comparative study of ZD1839 250 mg or 500 mg (Iressatm) given either continuously or concomitantly with cisplatin plus radiotherapy for the treatment of patients with previously untreated unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of written informed consent
- •2.Female or male patients aged 18 years and over
- •3.Patients must have measurable disease according to RECIST
- •4.Presence of stage III or IVA (Appendix L) squamous cell carcinoma of the head and neck confirmed histologically by biopsy or by fine needle aspiration at the time of diagnosis
- •5.No previous surgery to the tumour except for biopsy and not scheduled for surgery
- •6.No previous chemotherapy or radiotherapy for any neoplasm/tumour
- •7.No previous anti-EGFR therapy
- •8.Life expectancy ³12 weeks.
- •9.World Health Organisation (WHO) Performance Status of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Buccal mucosal carcinomas and post-nasal space (nasopharyngeal carcinoma), thyroid, sinus or salivary gland tumours and Grade III laryngeal carcinoma
- •2.Early stage III cancers (T1N1 or T2N1), Extensive disease (T4b) or metastatic disease (M1)
- •3.Disease invading the mandible
- •4.The presence of simultaneous primary tumours
- •5.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
- •6.Known severe hypersensitivity to cisplatin or any of the excipients of this product
- •7.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •8.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •9.Absolute neutrophil counts (ANC) £1.0 x 109/litre (L) or platelets £100 x 109/L
- •10.Serum bilirubin ³3 times the upper limit of the reference range (ULRR)
- •11.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the ULRR
- •12.Calculated creatinine clearance (Cockcroft and Gault) £60 ml/min
- •13.Serum calcium above the ULRR
- •14.As judged by the investigator, any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •15.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •16.Pregnancy or breastfeeding.
- •17.Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, amifostine, erythropoietin or St. John’s Wort
- •18.Concomitant use of CYP3A4 inhibitors (e.g., itraconazole)
- •19.Treatment with a non-approved or investigational drug within 30 days before
- •Day 1 of study treatment
- •20.Evidence of ototoxicity or other neurotoxicity
- •21.Concurrent treatment with other experimental drugs and/or anticancer agents
研究者
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