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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773188
First received: October 15, 2008
Last updated: September 22, 2014
Last verified: September 2014

October 15, 2008
September 22, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 tolerabilit y of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An i nitial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in com bination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisp latin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standar d treatment protocol). If no dose-limiting toxicities are observed, a second coh ort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in c ombination 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 t he target sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00773188
BO21247
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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