An open-label, non-controlled study of bevacizumab in combination with cisplatin-gembitabine or carboplatin-paclitaxel, as first line treatment for patients with advanced or recurrent squamous non-sma...

Mise à jour : Il y a 5 ans
Référence : EUCTR2005-005533-35

An open-label, non-controlled study of bevacizumab in combination with cisplatin-gembitabine or carboplatin-paclitaxel, as first line treatment for patients with advanced or recurrent squamous non-small cell lung cancer (NSCLC)

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Extrait

To assess the feasibility of using bevacizumab plus cisplatingemcitabine or carboplatin-paclitaxel in patients with squamous NSCLC considered to be at major risk for pulmonary haemorrhage*, when using preventive measures** to reduce the risk of pulmonary haemorrhage. *Patients considered at major risk of pulmonary haemorrhage, when treated with bevacizumab, are defined as presenting with central tumours of any size or peripheral tumours ≥ 2 cm in their longest diameter that have not been previously irradiated. **The preventive measures to reduce the risk of pulmonary haemorrhage in patients treated with bevacizumab are: - exclusion of patients with history of ≥ grade 2 haemoptysis (bright red blood of at least ½ teaspoon) in the 3 months prior to inclusion in the study - a short course of radiation therapy 3 weeks prior to starting chemotherapy - delay of the first administration of bevacizumab to the second cycle of chemotherapy.


Critère d'inclusion

  • Advanced or recurrent squamous non-small cell lung cancer in patients who are candidates for platinum-based chemotherapy and who have not received prior chemotherapy for metastatic or recurrent disease