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 progressio

• Conditions: advanced non-small cell lung cancer

• Registration Number: EUCTR2007-005523-15-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified