A phase I and randomised phase II study of Docetaxel and RAD001 (Everolimus) in advanced/recurrent or metastatic squamous cell carcinoma of the head and neck - DORA

niversity College London0 个研究点开始时间: 2007年12月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-Histologically confirmed advanced/recurrent or metastatic squamous cell carcinoma of the head and neck
•-Life expectancy >= 12 weeks
•-ECOG 0 or 1
•-Measurable disease (RECIST criteria)
•-Age >= 18 years
•-Written informed consent and able to attend for treatment and follow-up
•-Adequate haematological, renal and liver function
•-Patients may have received one line prior chemotherapy (not taxanes)
•-Patients may have received prior radiotherapy (completed >= 6 months prior to recruitment)
•-Negative pregnancy test (women of CBP) and willing to use approved contraception method (all patients)
•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

•-Potentially curable disease
•-Disease relapsed within 6 months of radiotherapy
•-Patients with locally advanced disease for whom radiotherapy is indicated
•-Previous chemotherapy for any cancer, except for head and neck cancer
•-Previous therapy with any erbB inhibitors (except Cetuximab given radiotherapy, as indicated in treatment algorithm)
•-Treatment within the last 4 weeks with any investigational drug
•-The current use of drugs which are known to inhibit CYP3A4 (except dexamethasone), or block P-glycoprotein including grapefruit juice
•-Evidence of the presence of central nervous system metastases
•-Evidence of uncontrolled infection
•-Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
•-History of hypersensitivity to docetaxel or any of its excipients
•-Pregnant or breast-feeding

发起方

niversity College London