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A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.

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ClinicalTrials.gov Identifier: NCT00773188
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

October 15, 2008
October 16, 2008
November 2, 2016
December 2008
October 2010   (Final data collection date for primary outcome measure)
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status. [ Time Frame: Throughout study ]
Same as current
Complete list of historical versions of study NCT00773188 on ClinicalTrials.gov Archive Site
Tumor response [ Time Frame: Week 13 and Week 22 ]
Same as current
Not Provided
Not Provided
 
A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer.
A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer
This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
  • Drug: bevacizumab [Avastin]
    7.5mg/kg iv or 15mg/kg iv every 3 weeks
  • Drug: cisplatin
    75mg/m2 iv according to a standard chemotherapy treatment protocol
  • Drug: vinorelbine
    15mg/m2 iv according to a standard chemotherapy treatment protocol
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: cisplatin
  • Drug: vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
  • ECOG performance status of 0 or 1;
  • no prior thoracic head and neck irradiation or surgical resection for current lung cancer.

Exclusion Criteria:

  • mixed, non-small cell and small cell tumors;
  • mixed adeno-squamous carcinomas with a predominant squamous component;
  • evidence of tumor invasion or encasement of major vessels;
  • history of grade >=2 hemoptysis;
  • presence of cavitations in lung lesions at baseline.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00773188
BO21247
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP