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Brief Title: AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Official Title: Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT00961415
Brief Summary: This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Beziers, , France
, Bordeaux, , France
, Bron, , France
, Caen, , France
, Caen, , France
, Clermont-ferrand, , France
, Creteil, , France
, GAP, , France
, Gleize, , France
, La Source, , France
, La Tronche, , France
, Lille, , France
, Limoges, , France
, Lyon, , France
, Marseille, , France
, Nancy, , France
, Nimes, , France
, Paris, , France
, Paris, , France
, Paris, , France
, Perpignan, , France
, Pierre Benite, , France
, Reims, , France
, Saint Priest En Jarez, , France
, Strasbourg, , France
, Toulon, , France
, Tours, , France
, Augsburg, , Germany
, Bad Berka, , Germany
, Berlin, , Germany
, Bonn, , Germany
, Ebensfeld, , Germany
, Frankfurt, , Germany
, Freiburg, , Germany
, Gauting, , Germany
, Grosshansdorf, , Germany
, Halle (Saale), , Germany
, Hamburg, , Germany
, Immenhausen, , Germany
, Karlsruhe, , Germany
, Leipzig, , Germany
, Minden, , Germany
, Muenchen, , Germany
, Oldenburg, , Germany
, Alexandroupolis, , Greece
, Napoli, Campania, Italy
, Aviano, Friuli-Venezia Giulia, Italy
, Roma, Lazio, Italy
, Novara, Piemonte, Italy
, Lecce, Puglia, Italy
, Sassari, Sardegna, Italy
, Pisa, Toscana, Italy
, Padova, Veneto, Italy
, Bundang City, , Korea, Republic of
, Daegu, , Korea, Republic of
, Gyeonggi-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Amersfoort, , Netherlands
, Amsterdam, , Netherlands
, Breda, , Netherlands
, Den Haag, , Netherlands
, Eindhoven, , Netherlands
, Haarlem, , Netherlands
, Hertogenbosch, , Netherlands
, Nieuwegein, , Netherlands
, Rotterdam, , Netherlands
, Sittard-Geleen, , Netherlands
, Zaandam, , Netherlands
, Balashikha, , Russian Federation
, Irkutsk, , Russian Federation
, Krasnodar, , Russian Federation
, Moscow, , Russian Federation
, St Petersburg, , Russian Federation
, Palma de Mallorca, Islas Baleares, Spain
, Las Palmas de Gran Canaria, Las Palmas, Spain
, La Laguna, Tenerife, Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Gävle, , Sweden
, Linköping, , Sweden
, Lund, , Sweden
, Uppsala, , Sweden
, Zürich, , Switzerland
, Antalya, , Turkey
, Izmir, , Turkey
, Al Ain, , United Arab Emirates
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR