A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
NCT ID: NCT00661778
Last Updated: 2014-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2007-07-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Cisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
Docetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.
Interventions
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Bevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
Cisplatin
Bevacizumab was supplied as a sterile liquid in glass vials.
Docetaxel
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IIIb or IV non-small cell lung cancer.
* Chemotherapy-naive.
Exclusion Criteria
* Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
* Recent or current chronic treatment with aspirin (\> 325 mg/day).
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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Palma de Mallorca, Balearic Islands, Spain
Cadiz, Cadiz, Spain
Castellon, Castellon, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
Alcalá de Henares, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Palencia, Palencia, Spain
Sagunto, Valencia, Spain
Valencia, Valencia, Spain
Valladolid, Valladolid, Spain
Valladolid, Valladolid, Spain
Zamora, Zamora, Spain
Countries
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Other Identifiers
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2006-005619-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML20081
Identifier Type: -
Identifier Source: org_study_id
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