A Phase II Trial of Erlotinib as first line therapy in Non- Small Cell Lung Cancer over-expressing EGFR - Study of targeted Erlotinib treatment for Non-small cell lung cancer

Oxford Radcliffe Hospitals NHS Trust0 个研究点目标入组 35 人开始时间: 2007年4月17日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Histologically or cytologically proven NSCLC, Stage IIIb/IV
•Immunocytochemical evidence of EGFR over expression (++ or +++) from diagnostic tissue (e.g. bronchoscopic tumour samples core biopsies, fine needle aspirates-FNA).
•Life expectancy of at least 12 weeks
•World Health Organisation (WHO) performance status of 0-2
•Haematological and biochemical indices within the ranges shown below. These measurements must be performed within two weeks before the patient goes on study. Haemoglobin (Hb)=9.0 g/dl.
•Neutrophils=1.5 x 10 to the power 9/L. Platelets=100 x 10 to the power 9/L. Serum bilirubin =1.5 x upper normal limit.
•Aspartate amino-transferase (AST) = 2.5 x upper limit of normal (ULN).
•Calculated creatinine clearance =50 ml/min.
•18 years or over
•Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
•RECIST criteria measurable disease at baseline.
•Ability to take oral medication
•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

•Previously treated with combination chemotherapy as first line treatment of NSCLC.
•Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks.
•Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy and are deemed at low risk for recurrence, are eligible for the study.
•Known primary brain tumours or brain metastases.
•Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use appropriate medically approved contraception for four weeks before starting trial treatment, during the trial and for six months afterwards are considered eligible.
•At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
•Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
•Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
•Anticoagulant, antifibrinolytic therapy

发起方

Oxford Radcliffe Hospitals NHS Trust