EUCTR2006-002667-33-BE进行中（未招募）不适用
Phase I/II study on induction chemotherapy followed by chemoradiation with or without lapatinib, a dual EGFR/ErbB2 kinase inhibitor, in patients with locally advanced resectable larynx and hypopharynx squamous cell carcinoma
European Organisation for Research and Treatment of Cancer0 个研究点开始时间: 2007年3月23日最近更新:
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
- •Histologically proven newly diagnosed laryngeal and hypopharyngeal
- •? Patients with T3 or T4 larynx or T2, T3 T4 hypopharynx
- •? Nodal status must be N0, N1, N2a, N2b, N2c and N3
- •? Patients must consent to access of their biological material for EGFR
- •status and must consent to PET
- •? Patient must have tumors amenable to surgery
- •? Absence of distant metastasis
- •? No prior treatment for head and neck cancer
- •? Age above 18
- •? WHO PS 0-2
- •? Normal hematological functions: neutrophils superior or equal to 1.5
- •x109 cells/l, platelets superior or equal to 100 x109 cells/l.
- •? Normal liver functions: bilirubin < 1.5 times the upper limit of the
- •normal range; alkaline phosphatase and transaminases inferior to 2.5 the
- •upper limit of the normal range.
- •? Serum creatinine lower than or equal to 150 µmol/l (< 1.7mg/dl).
- •? Patients should be able to swallow oral agents.
- •? Patients having normal cardiac function (LVEF assessed by MUGA or
- •ECHO), clinically satisfactory 12 lead ECG, and in the past 6 months
- •no serious cardiac illness or medical condition including but not
- •confined to:
- •- History of documented congestive heart failure (CHF)
- •- High-risk uncontrolled arrhythmias
- •- Angina pectoris requiring antianginal medication
- •- Clinically significant valvular heart disease
- •- Evidence of transmural infarction on ECG
- •- Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic
- •greater than 100mm Hg)
- •? Drugs and several HERBAL CONSTITUENTS (e.g. bergamottin and
- •glabridin), which are inducers or inhibitors of CYP3A4 must not be
- •taken within 10 days prior to initiation of treatment and are prohibited
- •while the patient is being treated with lapatinib (a detailed list is
- •provided in chapter 5)
- •? All patients (male and female) must use effective contraception
- •methods according to CPMP/ICH/286/95 if of reproductive potential
- •(e.g. implants, injectables, combined oral contraceptives, IUDs, sexual
- •abstinence or vasectomised partner). Contraception methods should be used from 2 weeks before the start of treatment and until 4 weeks after the end of treatment.
- •- Females must not be pregnant (negative serum pregnancy test at entry) or lactating
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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