EUCTR2004-002662-38-LT进行中（未招募）不适用
A PHASE III RANDOMISED, STRATIFIED, PARALLEL-GROUP, MULTI-CENTRE, COMPARATIVE STUDY OF ZD1839 (IRESSA®) 250 MG AND 500 MG VERSUS METHOTREXATE FOR PREVIOUSLY TREATED PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK - IMEX
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 477
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 informed consent
- •2.female or male patients aged 18 years and over
- •3.histological confirmation of evidence of squamous cell carcinoma of the head and neck diagnosed by biopsy or fine needle aspiration (FNA) at initial presentation
- •4.Stratum A:
- •Patients must have had radiotherapy or chemoradiotherapy as primary treatment and must have received at least a course of 2 cycles of platinum-based chemotherapy for recurrent disease and response to the most recent course of platinum-based chemotherapy must have been either progressive disease (radiologically documented) orstable disease (radiologically documented) after at least 2 cycles of platinum based chemotherapy.
- •Stratum B. Patients whose tumours have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy, due to performance status 2, decreased creatinine clearance, cardiac status or refusal of such chemotherapy (by the investigator) due to potential toxicity.
- •5.no prior anti-EGFR or methotrexate therapy
- •6.life expectancy ³8 weeks
- •7.WHO Performance Status 0, 1 or 2
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumours
- •2.isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
- •3.known severe hypersensitivity to ZD1839, methotrexate or any of the excipients of these products
- •4.other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •5.any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •6.any third space accumulation of fluid (oedema, effusion, ascites)
- •7.absolute neutrophil counts =1.5 x 109/L or platelets =100 x 109/L
- •8.serum bilirubin =1.25 times the upper limit of the reference range (ULRR)
- •9.alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) > 2.5 times the ULRR if no demonstrable liver metastases, or > 5 times the ULRR in the presence of liver metastases
- •10.evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- •11.as judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •12.evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •13.pregnancy or breast feeding (women of child-bearing potential)
- •14.concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
- •15.treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- •16.intra-cerebral metastases unless diagnostic imaging demonstrates no peritumoural oedema or progression since last scan (with at least 4-6 weeks between scans), the patient does not require corticosteroids, and the patient is asymptomatic from the metastases
- •17.concurrent treatment with other experimental drugs and/or anticancer agents
研究者
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