EUCTR2014-001523-69-IT进行中（未招募）不适用
Preclinical and clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of head and neck - Valproic acid – Cisplatin and Cetuximab in Head And Neck CancEr
Istituto Nazionale Tumori di Napoli - Fondazione G. Pascale0 个研究点目标入组 39 人开始时间: 2014年6月5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
- 39
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.Histologically or cytologically proven HPV negative squamous cell carcinoma of head and neck with the exclusion of nasopharyngeal cancer
- •2.First-line recurrent and/or metastatic disease
- •3.No prior chemotherapy except for chemoradiation or induction chemotherapy followed by local treatment given in the context of a curative strategy.
- •4.age> 18 years
- •5.ECOG Performance Status =1
- •6.Life expectancy at least 3 months at study entrance
- •7.Normal bone marrow reserve (absolute neuthrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin> 9 g/dl)
- •8.Normal hepatic function (total serum bilirubin < 1.5 x upper limit of normal; liver transaminases < 3 x upper limit of normal)
- •9.Normal renal function (serum creatinine < 1,25 x upper limit of normal and creatinine clearance > 60 ml/min).
- •10.Normal cardiac function (assessed by ECG and ecocardiography with ejection fraction > 50%)
- •11.Effective contraception for both male and female patients if the risk of conception exists.
- •12.Signed written informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Concomitant treatment with other experimental drugs.
- •2. Brain metastases (CT scan or MRI required only in case of clinical suspicion of CNS metastases)
- •3. Non squamous cell histology
- •4. Any concurrent malignancy. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial.
- •5. History of myocardial infarction within the last 12 months
- •6. ECOG PS = 2
- •7. Significant cardiovascular comorbidity (e.g. myocardial infarction, superior vena cava [SVC] syndrome, patients with an ejection fraction of <50%) or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •8. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Patients with long QT-syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc.
- •9. HIV positive patients
- •10. Patients who cannot take oral medication, who require intravenous feeding, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- •11. Known or suspected hypersensitivity to any of the study drugs.
- •12. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.
- •13. Major surgical procedure, within 28 days prior to study treatment start.
- •14. Pregnant or lactating women.
- •15. Women of childbearing potential with either a positive or no pregnancy test at baseline (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •16. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
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