A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
NCT ID: NCT00531960
Last Updated: 2014-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2008-01-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m\^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m\^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m\^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (\*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Standard platinum-based chemotherapy
At the discretion of the investigator
Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
Erlotinib
150 mg, PO, daily
Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Interventions
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Erlotinib
150 mg, PO, daily
Bevacizumab
15 mg/kg, IV, Day 1 of Cycles 1 through 7
Standard platinum-based chemotherapy
At the discretion of the investigator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* advanced (stage IIIb and IV) non-small cell lung cancer;
* measurable disease;
* ECOG PS 0-1.
Exclusion Criteria
* radiotherapy within 4 weeks prior to first dose of study treatment;
* CNS metastases;
* other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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East Bentleigh, Victoria, Australia
Geelong, Victoria, Australia
Leuven, , Belgium
Bayonne, , France
Dijon, , France
Le Mans, , France
Marseille, , France
Paris, , France
Strasbourg, , France
Vandœuvre-lès-Nancy, , France
Aviano, Friuli Venezia Giulia, Italy
Milan, Lombardy, Italy
Ancona, The Marches, Italy
Lido di Camaiore, Tuscany, Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
's-Hertogenbosch, , Netherlands
Amsterdam, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Heerlen, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Lodz, , Poland
Lublin, , Poland
Otwock, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Timișoara, , Romania
Singapore, , Singapore
Bundang City, , South Korea
Daegu, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Alicante, Alicante, Spain
Barcelona, Barcelona, Spain
A Coruña, La Coruña, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Seville, Sevilla, Spain
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Dudley, , United Kingdom
Guildford, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.
Other Identifiers
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BO20571
Identifier Type: -
Identifier Source: org_study_id