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 sitesJune 11, 2008

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Radboud University Medical Centre

•\-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

•\-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.