EUCTR2011-002564-24-IT进行中（未招募）不适用
Cetuximab and Cisplatin with or without Paclitaxel in recurrent/metastatic head and neck cancer
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2012年3月7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
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
- •Signed written informed consent
- •- Male or female > 18 years of age
- •- Histologically or cytologically confirmed diagnosis of SCCHN
- •- Confirmed RM SCCHN (oral cavity, oropharynx, larynx, hypopharynx, paranasal sinus), not suitable for local therapy
- •- At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT) must be present
- •- At least 6 months since completion of systemic chemotherapy or biologic therapy
- •- ECOG Performance Status 0-1
- •- Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, haemoglobin > 9 g/dL
- •- Adequate liver function: bilirubin < 2 X upper normal limit (except from known medical reason not interfering with liver function, such as Gilbert disease), SGOT, SGPT, AP, GGT < 3 x ULN
- •- Adequate renal function: calculated or analysed creatinine clearance > 60 mL/min
- •- Tumor tissue of primary or recurrent disease available
- •- Blood samples collected before and during the study available
- •- If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 2 months post-dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •No previous chemotherapy or biological therapy for recurrent/metastatic disease
- •- Nasopharyngeal Tumor
- •- Surgery (excluding prior diagnostic biopsy, tracheostomy or gastrostomy), or irradiation within 4 weeks before study entry
- •- Other serious illnesses or medical conditions:
- •- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months;
- •- Significant neurologic or psychiatric disorders including dementia or seizures;
- •- Active uncontrolled infection (requiring IV antibiotics) or known HIV positivity and active tubercolosis;
- •- Active disseminated intravascular coagulation;
- •- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- •- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC V 4.0) grade =2 and/or ototoxicity grade =2, except if due to trauma or mechanical impairment due to tumor mass;
- •- Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease;
- •- Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry;
- •- Chronic systemic immunosuppressive therapy that can not be interrupted during treatment study;
- •- Known allergic/hypersensitivity reaction to any of the components of the treatment;
- •- Pregnancy (absence confirmed by serum/urine beta HCG) or breast-feeding;
- •- Other active malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
- •- Legal incapacity or limited legal capacity;
- •- Medical, psychological or socio-geographical condition or situation which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
研究者
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