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A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

05:39 EDT 24th May 2013 | BioPortfolio

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)

View Results

Links

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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