A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800202
First received: December 1, 2008
Last updated: March 3, 2014
Last verified: March 2014

December 1, 2008
March 3, 2014
April 2009
October 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800202 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

This study will assess the efficacy and safety of Avastin combined with first line paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patients with non-squamous non-small cell lung cancer with asymptomatic untreated brain metastasis. Two cohorts of patients will be studied; the first will receive Avastin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv plus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line Tarceva 150mg/kg po.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab [Avastin]
    15mg/kg iv every 3 weeks
  • Drug: paclitaxel
    200mg/m2 iv every 3 weeks for 6 cycles
  • Drug: carboplatin
    AUC6 iv every 3 weeks for 6 cycles
  • Drug: erlotinib [Tarceva]
    150mg/day po
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: paclitaxel
    • Drug: carboplatin
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • stage IV non-squamous non-small cell lung cancer;
  • asymptomatic, untreated brain metastasis;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous treatment for brain metastasis;
  • history of migraine or epilepsy;
  • previous treatment with angiogenesis inhibitors;
  • for cohort 2, previous first line treatment with Avastin or Tarceva;
  • current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00800202
ML21823, 2008-006504-33
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2014

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