A phase II study of carboplatin –paclitaxel with bevacizumab followed by the addition of erlotinib to bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy. - bevacizumab plus erlotinib beyond progression

Radboud University Medical Centre0 个研究点开始时间: 2008年6月11日最近更新: 2012年3月19日

试验速览

暂无简介。

•-Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV) excluding squamous cell histology, with measurable or evaluable disease.
•-No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry.
•-ECOG Performance status 0-1
•-Age 18 or higher
•-No Known brain metastases.
•-No Prior treatment with bevacizumab or erlotinib
•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

•-lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, or with significant cavitation as assessed by treating investigator in consultation with an attending radiologist
•-evidence of bleeding diathesis or coagulopathy.
•-use of full dose anti-coagulant agents.
•-major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start, anticipation of need for major surgical procedure during the course of the study.
•-minor surgical procedures, fine needle aspirations or core biopsies within 7 days
•-history of hemoptysis (bright red blood of 1/2 teaspoon or more).
•-significant cardio-vascular co-morbidity
•-uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
•prior to start.

发起方

Radboud University Medical Centre