EUCTR2005-003814-14-ES进行中（未招募）不适用
Pharmacodynamic study of Erlotinib (Tarceva) in patients with mestastatic or locally advanced Epidermoid carcinoma of the head and neck
nidad Integral de Investigación en Oncología, S.L.0 个研究点目标入组 49 人开始时间: 2006年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
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
- •Aceptation of the patiens to participate in the trial with their written consent prior to the commencement of the trial-related procedures.
- •Patients with a histological proven diagnosis of cancer of head and neck incurable with other treatments of cirugy and radiotherapy.The nor distinghised carcinomas and not queratinizados as linfoepiteliomas in aereas of cancer of parotida glándula except: Patients with cancer de squamous cell WHO tipo I of nasofaringe.
- •Ages 18-70 years
- •Life-expectancy >12 weeks
- •Measurable disease,RECIST criteria
- •Fulfifment of the treatment and the patiens must be geographically accessible for treatment and follow-up.
- •If the patients have received a prior treatment:
- •Chemotherapy: the patients musn,t have received more of 2 cycles of chemotherapy to the the treatment of the local disease and/or metastasic.The patients that have received the induction o chemoradiotherapy with a healing intention to local disease can participate in the trial if they have not received more of 2 cycles of chemotherapy to the recurrent disease. That treatment must have completed at least 14 days prior to the commencement of the trial.Every patients must have recovered of the toxic sever effects in relation with the prior treatment.The prior treatment of diana treatment such as inhibidores of tirosin quinasa and monoclonales antibodys.
- •Radiotherapy:prior radiotherapy treatment is allowed if the patients
- •have recovered of the toxic sever effects in relation the treatment before to start the trial.It must have been passed 14 days since the end of the radiotherapy treatment. The disease progression in a previous irradiated area must be demonstrated by byopsia or tomografic image.
- •previous surgery: it is possible it the injury has healed and the surgery has been performed 14 days before the start of the trial
- •TArget lesion >=20mm (or >=10mm CT spiral). If the area is a previous irradiated area it must be documented the disease progression or to be present a residual cancer demonstrated by byopsia
- •Optima organic function according to: a)adequate medular function, ANC>1.5x109L, platelets>100x109L and hemoglobin>9g/dl
- •b)adequate hepatic and renal function
- •negative pregnancy test
- •Good cardiovascular function
- •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
- •Not writen informed consent.
- •Another medical treatment with experimental drugs or another simultaneous chemotherapeutic drugs during the study.
- •Patients with different histologic diagnosis of epidermoid carcinoma.
- •Another previous neoplasia, except basal cell carcinoma or squamous carcinoma of skin, previous treated; resecate cervix carcinoma.
- •Pregnant or lactancy women.
- •Patiens with active infection
- •Serious concomitant disease or patients with life expectancy smallest than their neoplasic disease.
- •Serious psychiatric disease not controled.
- •Patients unable to take oral medication or patients whose take intravenous food or patients with an intervention which interferes to the apsortion or patients with active peptic ulcer.
- •Follow-up not possible.
- •Symptomatic unstable metastasic brain, not controled with esteroids, life potential menace or with radiotherapy in the 14 days before the beginning of the study.
- •Any disease, metabolic malfunction, abnormal physical exploration or analytic information who suggest an inconvenient condition for the administration of the trial medication that might affect the study results or increase the risk of patient treatment.
- •Frequent vomits or medical disease who interferes to oral ingestion of medicaments.
研究者
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