A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
Summary
This study will assess the efficacy and safety of Avastin combined with first line paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patients with non-squamous non-small cell lung cancer with asymptomatic untreated brain metastasis. Two cohorts of patients will be studied; the first will receive Avastin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv plus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line Tarceva 150mg/kg po.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Non-small Cell Lung Cancer
Intervention
bevacizumab [Avastin], paclitaxel, carboplatin, erlotinib [Tarceva]
Location
Bordeaux
France
33076
Status
Recruiting
Source
Hoffmann-La Roche
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00800202
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Paclitaxel
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
Carboplatin
An organoplatinum compound that possesses antineoplastic activity.
Small Cell Lung Carcinoma
A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).
Carcinoma, Bronchogenic
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Lymphoma, Mantle-cell
A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).
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